A Phase 1/2 interventional study of Trilaciclib and Placebo in Small Cell Lung Cancer, sponsored by G1 Therapeutics, Inc.. Completed at 50 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by G1 Therapeutics, Inc. (part of Pharmacosmos A/S) · Phase 1/2, Interventional, and Treatment
Among 629 studies in Small Cell Lung Carcinoma with a site in United States — 111 open to participants now, 182 under way, 26 of them phase 3. Small Cell Lung Carcinoma · United States.
Among the 629 studies in Small Cell Lung Carcinoma with a site in United States, this one is the 161st largest by enrollment of the 550 interventional ones that give a count, is one of 18 that started in 2015, is one of 113 in phase 1/2, and was the 300th registered.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 365 are open to participants now.
Browse Small Cell Lung Carcinoma studies →111 of the 629 studies in Small Cell Lung Carcinoma with a site in United States are open now. Recruiting first, the newest first:
Misty Shields · Sites in United States
Ages 18+
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 18+
Boehringer Ingelheim · Sites in United States, Australia, Belgium and 8 more countries
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
Jazz Pharmaceuticals · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 263 Small Cell Lung Carcinoma studies recruiting now, 173 (66%) set no upper age limit and 66 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
629 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 295 · Phase 2 303 · Phase 3 54 · Phase 4 3
First in 1991; this study’s year is marked. 18 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 123 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Median enrollment 55 across the 550 interventional studies, 111 across the 51 observational. Of the 417 that completed or were terminated, 173 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
294 of 629 have an industry lead sponsor. The 10 most frequent:
This study is registered under G1 Therapeutics, Inc., one of the names counted as Pharmacosmos A/S. Under that name alone:
G1 Therapeutics, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
Pharmacosmos A/S has 6 studies filed under Small Cell Lung Carcinoma — fewer than ten, so there is no comparison to draw.
44 of the studies in Small Cell Lung Carcinoma with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01064466Phase 3Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB ChairPharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT06646276Phase 3Bristol-Myers SquibbA Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). | 2027-08-17 |
| NCT07778316Phase 3AmgenPhase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC) | 2027-09-24 |
| NCT04624204Phase 3Merck Sharp & Dohme LLCPlacebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) | 2027-10-28 |
| NCT07473128Phase 3Pharmacosmos A/SEffect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer | 2027-10-31 |
Add all 44 to your calendar (.ics) → With an account.
Among the 629 studies in Small Cell Lung Carcinoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced myelosuppression and improve anti-tumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC.
The study consisted of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit.
Overall, up to 130 patients were planned to be enrolled in the study. In Part 1, approximately 40 patients were planned to be enrolled, assuming 9 to 10 cohorts. Part 1 was open-label, and no randomization or blinding was required. In Part 2A, approximately 45 patients were to be enrolled and randomly assigned (2:1) to trilaciclib (240 mg/m2) and topotecan (0.75 mg/m2) or placebo and topotecan (1.5 mg/m2). In Part 2B, approximately 45 patients were to be enrolled and randomly assigned (2:1) to trilaciclib (240 mg/mg2) and topotecan (1.5 mg/m2) or placebo and topotecan (1.5 mg/m2).
Patients who received placebo in Part 2A and Part 2B were to be combined into a single placebo group for the analysis to compare with trilaciclib+topotecan 1.5 mg/m2 with placebo + topotecan 1.5 mg/m2 (proximately 30 per treatment group).
The sample size calculation was to demonstrate the superiority of trilaciclib + topotecan 1.5 mg/m2 over placebo + topotecan 1.5 mg/m2 with respect to at least 1 of the primary endpoints. The overall type I error rate was 1-sided 0.10. Using the most conservative Bonferroni procedure for the 2 primary endpoints, a 1-sided individual type I error rate 0.10/2=0.05 was assigned to each outcome variable (DSN in Cycle 1 and occurrence of SN) in the sample size calculation. Assuming a common standard deviation of 2.5, a difference in the duration of SN in Cycle 1 of at least 2 days between the treatment groups, a sample size of 28 per arm was required to have 90% power to detect the assumed treatment effect. For occurrence of SN, assuming the event rate was 45% for placebo group, to detect an absolute reduction of 37% by trilaciclib group with 90% power would require a sample size of at least 29 per arm. Thus, 30 per arm was needed to ensure 90% power to detect assumed treatment effect for DSN in Cycle 1 and occurrence of SN. All calculations were carried out using the POWER procedure in SAS®, Version 9.4 procedure in SAS®, Version 9.4 or higher.
The results from endpoints that were commonly collected at Part 1 and part 2 are presented together in this report.
The posted results represent the final results of Study G1T28-03, a Phase 1b/2a safety and pharmacokinetic (PK) study of trilaciclib (G1T28) in patients with previously treated extensive-stage small cell lung cancer (SCLC) receiving topotecan chemotherapy in the second/third-line (2/3L) setting. The final myelopreservation efficacy results for both parts and exposure for Part 1 are from database lock 1 (data cut-off [DCO] for Primary Completion Date [PCD] 28 September 2018). The final anti-tumor efficacy (BOR, DOR, PFS) for both parts, final overall survival for Part 1 and exposure data from Part 2 are from a second database lock 2 (DCO 31 May 2019) and the final overall survival for Part 2 and safety (adverse events) are through the end of the study on October 4, 2021 which resulted in the final database lock (DCO 01 Nov 2021).
The maximum time frames provided reflect the time from when the first patient could be evaluated for an endpoint (ie. date of first dose of first patient) to the time when the data from both parts presented for that endpoint was considered final.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).
Drug: Placebo · Drug: Topotecan
Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Drug: Trilaciclib · Drug: Topotecan
Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).
Drug: Trilaciclib · Drug: Topotecan
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).
Drug: Trilaciclib · Drug: Topotecan
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).
Drug: Trilaciclib · Drug: Topotecan
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Drug: Trilaciclib · Drug: Topotecan
Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Drug: Trilaciclib · Drug: Topotecan
Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Drug: Trilaciclib · Drug: Topotecan
Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).
Drug: Trilaciclib · Drug: Topotecan
Also known as: G1T28, CDK 4/6 inhibitor
Duration of Severe (Grade 4) Neutropenia in Cycle 1
Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first ANC value of \<0.5 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10\^9/L that met the following criteria: (1) occurred after the ANC value of \<0.5 × 10\^9/L and (2) no other ANC values \<0.5 × 10\^9/L occurred between this day and end of cycle. DSN is set to 0 for patients who did not experience SN in a cycle, including those who were randomized but never treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.
Time frame: Evaluated for Cycle 1 (i.e., from date of first dose of study drug (Part 1)/randomization (Part 2) to the end of Cycle 1, each cycle = 21 days)
Occurrence of Severe (Grade 4) Neutropenia
Number of Participants with severe (Grade 4) neutropenia (SN) was a binary variable. If a patient had at least 1 absolute neutrophil count value \<0.5 × 10\^9/L during the Treatment Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Assess the Dose Limiting Toxicities (DLTs) of G1T28/Trilaciclib Administered With Topotecan in Part 1
The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including: * Absolute neutrophil count (ANC) \< 0.5 × 10\^9/L lasting for ≥ 7 days * ≥ Grade 3 neutropenic infection/febrile neutropenia * Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia with bleeding * Unable to start next cycle of chemotherapy due to lack of recovery to an ANC ≥ 1.5 × 10\^9/L and platelet count ≥ 100 × 10\^9/L; a delay of up to 1 week from the scheduled start of Cycle 2 is allowed for recovery of ANC and platelet count, and is not considered a DLT * ≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for \> 72 hours)
Time frame: Evaluated for Cycle 1 (i.e., from date of first dose of study drug (Part 1) to the end of Cycle 1, each cycle = 21 days)
Pharmacokinetic Profile for Trilaciclib (G1T28) When Administered With Topotecan
Maximum concentration (Cmax) of trilaciclib (G1T28) when administered with topotecan
Time frame: Part 1 of the study during Cycle 1 Day 4 : predose, 0.5, 1, 1.5, 2, 2.5, 3, 4.5, 6.5, 8.5 (optional), and 24.5 hours post dose. Part 2 of the study during Cycle 1 Day 4 : predose, 0.5, 1, between 3 to 4 hours and between 5.5 to 6.5 hours post dose.
Progression Free Survival (PFS)
Median time (months) and 95% CI from date of first dose of study drug/randomization until date of documented disease progression or death due to any cause. Investigators followed the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines for tumor assessments to determine progression. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: From date of first dose of study drug (Part 1)/randomization (Part 2), until date of documented disease progression or death due to any cause (evaluated up to a maximum of 1335 days).
Overall Survival (OS)
Median time (months) and 95% CI from date of first dose date of study drug/randomization until date of death. Patients who do not die during the study will be censored at the date last known to be alive.
Time frame: From date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2220 days).
Assess the Hematologic Profile of G1T28/Trilaciclib Administered With Topotecan
The weekly event rate of Major Adverse Hematologic Events (MAHE) events
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Tumor Response Based on RECIST, Version 1.1
The percentage of patients who fall into each category of Best overall response (BOR) as defined by RECIST, Version 1.1. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. When no imaging/measurement is done, the patient is not evaluable (NE); and if only a subset of lesion measurements are made, usually the case is also considered NE.
Time frame: From date of first dose of study drug (Part 1)/randomization (Part 2) until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, (assessed up to a maximum of 1335 days).
Occurrence of RBC Transfusions
Percentage of patients requiring a RBC transfusion on/after week 5
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1056 days).
Need for Treatment With Hematopoietic Growth Factors
Percentage of patients requiring G-CSF administration.
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Chemotherapy Cycles and Modifications Overall
Average exposure and cycle modifications in chemotherapy (topotecan)
Time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to a maximum of 1335 days).
Pharmacokinetic Profile for Topotecan When Administered With Trilaciclib (G1T28)
Maximum concentration (Cmax) of topotecan when administered with trilaciclib (G1T28)
Time frame: Part 1 of the study during Cycle 1 Day 4 : predose, 0.5, 1, 1.5, 2, 2.5, 3, 4.5, 6.5, 8.5 (optional), and 24.5 hours post dose. Part 2 of the study during Cycle 1 Day 4 : predose, 0.5, 1, between 3 to 4 hours and between 5.5 to 6.5 hours post dose.
Duration of Response (DOR)
The median months and 95% CIs of duration of response.
Time frame: From date of first dose of study drug (Part 1)/randomization (Part 2) until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, (assessed up to a maximum of 1335 days).
Occurrence of Intravenous (IV) Antibiotic Use
Percentage of patients requiring systemic/IV antibiotics
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Occurrence of Platelet Transfusions
Percentage of patients requiring a platelet transfusion
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Occurrence of Febrile Neutropenia Adverse Events
Percentage of patients who experience febrile neutropenia adverse events
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Occurrence of Infection Serious Adverse Events (SAEs)
Percentage of patients experiencing an SAE that codes to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of Infections and Infestations
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Occurrence of Pulmonary Infection Serious Adverse Events (SAEs)
Percentage of patients experiencing an SAE that codes to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of Infections and Infestations and falls into a preferred term (PT) categorized as a pulmonary infection custom MedDRA query (CMQ)
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Dose Reductions in Chemotherapy (Topotecan)
Overall event rate of dose reductions in chemotherapy (topotecan)
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Occurrence of Grade 3 and 4 Hematologic Toxicities
The count of patients with any hematologic lab value that meets the CTCAE toxicity grade criteria for ≥ Grade 3 and the value is treatment emergent (occurs after first dose of study drug). Labs include: Hemoglobin (HGB), hematocrit, white blood cell (WBC), platelet counts, ANC, ALC, Monocyte Absolute, Basophil Absolute, and Eosinophil Absolute.
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Occurrence of Grade 4 and Grade 3/4 Decreased Platelet Count Laboratory Values (Thrombocytopenia)
The count of patients with any platelet lab value that meets the CTCAE toxicity grade criteria for ≥ Grade 3 and the value is treatment emergent (occurs after first dose of study drug).
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Occurrence of Erythropoietin-stimulating Agent (ESA) Administrations
The count of patients who received any ESA administration.
Time frame: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
Chemotherapy Exposure
Average duration of exposure to chemotherapy (topotecan) in days.
Time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to a maximum of 1335 days).
| Milestone | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Started | 29 | 30 | 32 | 2 | 3 | 4 | 8 | 7 | 8 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 29 | 30 | 32 | 2 | 3 | 4 | 8 | 7 | 8 |
| Withdrew: Withdrawal by subject | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Death | 24 | 28 | 29 | 0 | 3 | 4 | 8 | 6 | 5 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Sponsor termination of study | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Study completion per investigator | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 1 |
Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first ANC value of \<0.5 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10\^9/L that met the following criteria: (1) occurred after the ANC value of \<0.5 × 10\^9/L and (2) no other ANC values \<0.5 × 10\^9/L occurred between this day and end of cycle. DSN is set to 0 for patients who did not experience SN in a cycle, including those who were randomized but never treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.
| days | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Duration of Severe (Grade 4) Neutropenia in Cycle 1 | 8 ± 6.0 | 1 ± 3.1 | 2 ± 3.9 | 14 ± 1.4 | 8 ± 6.8 | 0 ± 0 | 0 ± 0 | 2 ± 3.6 | 3 ± 5.5 |
Number of Participants with severe (Grade 4) neutropenia (SN) was a binary variable. If a patient had at least 1 absolute neutrophil count value \<0.5 × 10\^9/L during the Treatment Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Occurrence of Severe (Grade 4) Neutropenia | 22 | 5 | 13 | 2 | 2 | 1 | 0 | 2 | 3 |
The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including: * Absolute neutrophil count (ANC) \< 0.5 × 10\^9/L lasting for ≥ 7 days * ≥ Grade 3 neutropenic infection/febrile neutropenia * Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia with bleeding * Unable to start next cycle of chemotherapy due to lack of recovery to an ANC ≥ 1.5 × 10\^9/L and platelet count ≥ 100 × 10\^9/L; a delay of up to 1 week from the scheduled start of Cycle 2 is allowed for recovery of ANC and platelet count, and is not considered a DLT * ≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for \> 72 hours)
| Participants | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m²- Part 1 Cohort 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m²- Part 1 Cohort 2 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 3 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohorts 4 and 6 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 5 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m²- Part 1 Cohort 7 |
|---|---|---|---|---|---|---|
| Assess the Dose Limiting Toxicities (DLTs) of G1T28/Trilaciclib Administered With Topotecan in Part 1 | 2 | 2 | 2 | 0 | 2 | 2 |
Maximum concentration (Cmax) of trilaciclib (G1T28) when administered with topotecan
| ng/ml | Trilaciclib (G1T28) 200 mg/m² + Topotecan - Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan - Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan - Part 1 | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b |
|---|---|---|---|---|---|---|
| Pharmacokinetic Profile for Trilaciclib (G1T28) When Administered With Topotecan | 1060 ± 59.0 | 1220 ± 120 | 2220 ± 75.2 | — | 913 ± 59.6 | 1100 ± 54.8 |
Median time (months) and 95% CI from date of first dose of study drug/randomization until date of documented disease progression or death due to any cause. Investigators followed the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines for tumor assessments to determine progression. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
| months | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Progression Free Survival (PFS) | 4.2 (1.6 to 6.2) | 3.0 (1.7 to 3.6) | 4.2 (2.1 to 5.2) | 5.5 (NA to NA) | 4.3 (1.4 to 8.9) | 3.6 (2.1 to 4.2) | 4.5 (0.7 to 5.9) | 1.8 (1.3 to 6.9) | 2.1 (1.4 to 7.5) |
Median time (months) and 95% CI from date of first dose date of study drug/randomization until date of death. Patients who do not die during the study will be censored at the date last known to be alive.
| months | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Survival (OS) | 6.5 (3.5 to 11.3) | 5.8 (4.1 to 8.1) | 6.2 (4.0 to 9.9) | NA (NA to NA) | 10.6 (8.3 to 25.3) | 8.3 (4.5 to 11.8) | 9.4 (1.1 to 12.5) | 4.4 (2.1 to 10.0) | 10.0 (2.1 to NA) |
The weekly event rate of Major Adverse Hematologic Events (MAHE) events
| events per participant/week | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Assess the Hematologic Profile of G1T28/Trilaciclib Administered With Topotecan | 0.258 | 0.091 | 0.102 | 0.403 | 0.156 | 0.102 | 0.037 | 0.085 | 0.073 |
The percentage of patients who fall into each category of Best overall response (BOR) as defined by RECIST, Version 1.1. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. When no imaging/measurement is done, the patient is not evaluable (NE); and if only a subset of lesion measurements are made, usually the case is also considered NE.
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Complete Response (CR) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Partial Response (PR) | 5 | 3 | 5 | 1 | 2 | 0 | 1 | 0 | 1 |
| Stable Disease (SD) | 10 | 15 | 13 | 1 | 0 | 3 | 6 | 3 | 3 |
| Progressive Disease (PD) | 6 | 9 | 6 | 0 | 1 | 1 | 1 | 2 | 2 |
| Not Evaluable (NE) | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| No post-baseline tumor assessment (Missing) | 2 | 2 | 6 | 0 | 0 | 0 | 0 | 1 | 1 |
Percentage of patients requiring a RBC transfusion on/after week 5
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Occurrence of RBC Transfusions | 12 | 5 | 10 | 2 | 1 | 2 | 1 | 1 | 2 |
Percentage of patients requiring G-CSF administration.
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Need for Treatment With Hematopoietic Growth Factors | 19 | 8 | 16 | 2 | 2 | 1 | 4 | 2 | 3 |
Average exposure and cycle modifications in chemotherapy (topotecan)
| cycles | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Number of cycles completed | 4 ± 3.4 | 5 ± 5.4 | 5 ± 4.4 | 6 ± 0.0 | 7 ± 5.0 | 4 ± 1.7 | 6 ± 2.9 | 4 ± 3.4 | 4 ± 2.2 |
| Number of cycles delayed | 1 ± 1.2 | 2 ± 2.5 | 1 ± 1.4 | 3 ± 1.4 | 1 ± 1.2 | 1 ± 0.5 | 1 ± 0.8 | 0 ± 0.5 | 1 ± 1.0 |
Maximum concentration (Cmax) of topotecan when administered with trilaciclib (G1T28)
| ng/ml | Trilaciclib (G1T28) + Topotecan 0.75 mg/m²- Part 1 | Trilaciclib (G1T28) + Topotecan 1 mg/m²- Part 1 | Trilaciclib (G1T28) + Topotecan 1.25 mg/m²- Part 1 | Trilaciclib (G1T28) + Topotecan 1.50 mg/m²- Part 1 | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b |
|---|---|---|---|---|---|---|---|
| Pharmacokinetic Profile for Topotecan When Administered With Trilaciclib (G1T28) | 21.1 ± 34.6 | 36.8 ± 41.8 | 52.4 ± 66.5 | NA ± NA | 43.0 ± 39.0 | 17.5 ± 36.5 | 41.4 ± 46.9 |
The median months and 95% CIs of duration of response.
| months | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Duration of Response (DOR) | 4.9 (2.1 to NA) | 7.8 (4.1 to NA) | 6.8 (2.8 to NA) | NA (NA to NA) | 5.4 (3.1 to 7.7) | — | 6.7 (NA to NA) | — | NA (NA to NA) |
Percentage of patients requiring systemic/IV antibiotics
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Occurrence of Intravenous (IV) Antibiotic Use | 8 | 8 | 7 | 2 | 1 | 1 | 1 | 2 | 1 |
Percentage of patients requiring a platelet transfusion
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Occurrence of Platelet Transfusions | 9 | 4 | 8 | 0 | 1 | 0 | 0 | 1 | 0 |
Percentage of patients who experience febrile neutropenia adverse events
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Occurrence of Febrile Neutropenia Adverse Events | 5 | 1 | 2 | 0 | 0 | 0 | 0 | 1 | 0 |
Percentage of patients experiencing an SAE that codes to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of Infections and Infestations
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Occurrence of Infection Serious Adverse Events (SAEs) | 3 | 2 | 1 | 2 | 1 | 1 | 0 | 0 | 1 |
Percentage of patients experiencing an SAE that codes to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of Infections and Infestations and falls into a preferred term (PT) categorized as a pulmonary infection custom MedDRA query (CMQ)
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Occurrence of Pulmonary Infection Serious Adverse Events (SAEs) | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 |
Overall event rate of dose reductions in chemotherapy (topotecan)
| events per participant per cycle | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Dose Reductions in Chemotherapy (Topotecan) | 0.116 | 0.053 | 0.051 | 0.500 | 0.250 | 0.118 | 0.089 | 0.040 | 0.036 |
The count of patients with any hematologic lab value that meets the CTCAE toxicity grade criteria for ≥ Grade 3 and the value is treatment emergent (occurs after first dose of study drug). Labs include: Hemoglobin (HGB), hematocrit, white blood cell (WBC), platelet counts, ANC, ALC, Monocyte Absolute, Basophil Absolute, and Eosinophil Absolute.
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Occurrence of Grade 3 and 4 Hematologic Toxicities | 27 | 25 | 29 | 2 | 3 | 4 | 7 | 7 | 7 |
The count of patients with any platelet lab value that meets the CTCAE toxicity grade criteria for ≥ Grade 3 and the value is treatment emergent (occurs after first dose of study drug).
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Grade 3/4 Thrombocytopenia | 19 | 15 | 21 | 2 | 2 | 3 | 2 | 4 | 4 |
| Overall Grade 4 Thrombocytopenia | 11 | 9 | 13 | 2 | 1 | 2 | 0 | 2 | 1 |
The count of patients who received any ESA administration.
| Participants | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Occurrence of Erythropoietin-stimulating Agent (ESA) Administrations | 6 | 5 | 1 | 2 | 1 | 0 | 1 | 0 | 1 |
Average duration of exposure to chemotherapy (topotecan) in days.
| days | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| Chemotherapy Exposure | 94 ± 75.9 | 110 ± 132.1 | 109 ± 97 | 147 ± 9.9 | 147 ± 116.9 | 102 ± 38.9 | 124 ± 65.8 | 78 ± 74.9 | 83 ± 51.8 |
Collected over The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | 24/29 (82.8%) | 7/28 (25%) | 27/28 (96.4%) |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 28/30 (93.3%) | 15/30 (50%) | 29/30 (96.7%) |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 29/32 (90.6%) | 12/32 (37.5%) | 32/32 (100%) |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | 0/2 (0%) | 2/2 (100%) | 2/2 (100%) |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | 4/4 (100%) | 2/4 (50%) | 4/4 (100%) |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | 8/8 (100%) | 0/8 (0%) | 8/8 (100%) |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | 6/7 (85.7%) | 1/7 (14.3%) | 7/7 (100%) |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | 5/8 (62.5%) | 1/8 (12.5%) | 8/8 (100%) |
| Event | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 1/28 | 1/30 | 1/32 | 1/2 | 1/3 | 1/4 | 0/8 | 0/7 | 1/8 |
| Septic shockInfections and infestations | 0/28 | 0/30 | 0/32 | 1/2 | 0/3 | 0/4 | 0/8 | 0/7 | 0/8 |
| Metabolic encephalopathyNervous system disorders | 0/28 | 0/30 | 0/32 | 1/2 | 0/3 | 0/4 | 0/8 | 0/7 | 0/8 |
| Myocardial infarctionCardiac disorders | 0/28 | 0/30 | 0/32 | 0/2 | 1/3 | 0/4 | 0/8 | 0/7 | 0/8 |
| Pulmonary emobolismRespiratory, thoracic and mediastinal disorders | 0/28 | 2/30 | 0/32 | 0/2 | 0/3 | 1/4 | 0/8 | 0/7 | 0/8 |
| AnemiaBlood and lymphatic system disorders | 0/28 | 2/30 | 0/32 | 0/2 | 0/3 | 1/4 | 0/8 | 0/7 | 0/8 |
| Febrile neutropeniaBlood and lymphatic system disorders | 5/28 | 1/30 | 2/32 | 0/2 | 0/3 | 0/4 | 0/8 | 0/7 | 0/8 |
| FallInjury, poisoning and procedural complications | 0/28 | 0/30 | 0/32 | 0/2 | 0/3 | 0/4 | 0/8 | 1/7 | 0/8 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/28 | 0/30 | 0/32 | 0/2 | 0/3 | 0/4 | 0/8 | 1/7 | 0/8 |
| HyponatraemiaMetabolism and nutrition disorders | 0/28 | 4/30 | 1/32 | 0/2 | 0/3 | 0/4 | 0/8 | 0/7 | 0/8 |
| Event | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 |
|---|---|---|---|---|---|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 23/28 | 18/30 | 24/32 | 2/2 | 3/3 | 2/4 | 5/8 | 5/7 | 5/8 |
| ThrombocytopeniaBlood and lymphatic system disorders | 19/28 | 17/30 | 20/32 | 2/2 | 3/3 | 3/4 | 1/8 | 4/7 | 3/8 |
| AnaemiaBlood and lymphatic system disorders | 24/28 | 14/30 | 17/32 | 2/2 | 3/3 | 2/4 | 3/8 | 4/7 | 6/8 |
| LeukopeniaBlood and lymphatic system disorders | 9/28 | 7/30 | 4/32 | 2/2 | 3/3 | 1/4 | 2/8 | 2/7 | 3/8 |
| FatigueGeneral disorders | 10/28 | 16/30 | 13/32 | 2/2 | 3/3 | 2/4 | 4/8 | 1/7 | 4/8 |
| AstheniaGeneral disorders | 4/28 | 5/30 | 2/32 | 2/2 | 1/3 | 1/4 | 0/8 | 2/7 | 2/8 |
| NauseaGastrointestinal disorders | 14/28 | 16/30 | 9/32 | 0/2 | 3/3 | 2/4 | 3/8 | 4/7 | 3/8 |
| DiarrhoeaGastrointestinal disorders | 8/28 | 7/30 | 5/32 | 1/2 | 3/3 | 1/4 | 1/8 | 1/7 | 2/8 |
| ConstipationGastrointestinal disorders | 3/28 | 4/30 | 2/32 | 2/2 | 2/3 | 0/4 | 2/8 | 1/7 | 4/8 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/28 | 8/30 | 3/32 | 2/2 | 1/3 | 1/4 | 5/8 | 2/7 | 2/8 |
| Age, Categorical(Participants) | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 18 | 20 | 1 | 1 | 1 | 6 | 4 | 2 | 71 |
| >=65 years | 11 | 12 | 12 | 1 | 2 | 3 | 2 | 3 | 6 | 52 |
| Age, Continuous(Years) | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 64 ± 8.1 | 63 ± 8.2 | 62 ± 7.3 | 66 ± 9.2 | 69 ± 9.1 | 71 ± 6.1 | 62 ± 8.4 | 63 ± 8.9 | 69 ± 10.4 | 64 ± 8.2 |
| Sex: Female, Male(Participants) | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 17 | 14 | 10 | 0 | 2 | 0 | 5 | 0 | 4 | 52 |
| Male | 12 | 16 | 22 | 2 | 1 | 4 | 3 | 7 | 4 | 71 |
| Ethnicity (NIH/OMB)(Participants) | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 28 | 30 | 31 | 2 | 3 | 4 | 8 | 7 | 8 | 121 |
| Unknown or Not Reported | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 6 |
| White | 26 | 29 | 30 | 2 | 3 | 4 | 7 | 6 | 7 | 114 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| United States | 18 | 27 | 14 | 2 | 3 | 4 | 8 | 7 | 8 | 91 |
| Serbia | 11 | 3 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 26 |
| Belgium | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| North Macedonia | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Croatia | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Grade 0-1 | 27 | 27 | 29 | 2 | 3 | 4 | 6 | 7 | 7 | 112 |
| Grade 2 | 2 | 3 | 3 | 0 | 0 | 0 | 2 | 0 | 1 | 11 |
| Body Weight at Screening(kg) | Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 72.7 ± 16.37 | 71.9 ± 17.08 | 75.7 ± 17.28 | 95.2 ± 22.20 | 72.6 ± 23.59 | 90.1 ± 23.05 | 73.5 ± 29.88 | 86.3 ± 19.25 | 67.8 ± 15.00 | 74.7 ± 18.55 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2015 to primary completion in Sep 2018, 35 months.
Results were first posted in Jun 2022, 3 years 8 months after primary completion. A results delay was requested in Jul 2019.
Of 71 industry-sponsored phase 1/2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 74. This study's 35 months is below that.
Counting every sponsor, half of 98 studies reached it within 54 months; a quarter within 44 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trilaciclib