A Phase 3 interventional study of Trilaciclib and Placebo in Colorectal Cancer Metastatic, Myelosuppression-Adult and Chemotherapeutic Toxicity, sponsored by G1 Therapeutics, Inc.. Terminated at 82 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by G1 Therapeutics, Inc. (part of Pharmacosmos A/S) · Phase 3, Interventional, and Treatment
Among 2,338 studies in Colorectal Neoplasms with a site in United States — 420 open to participants now, 629 under way, 30 of them phase 3. Colorectal Neoplasms · United States.
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, this one is the 405th largest by enrollment of the 1,931 interventional ones that give a count, is one of 126 that started in 2021, is one of 117 in phase 3, and was the 1,553rd registered.
6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.
Browse Colorectal Neoplasms studies →420 of the 2,338 studies in Colorectal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
Exelixis · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 40–80 · Men only
University of Pennsylvania · 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 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 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.
2,338 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 1 817 · Phase 2 790 · Phase 3 132 · Phase 4 19
First in 1981; this study’s year is marked. 126 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 326 is above the median of 76 across 4,801 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 64 across the 1,931 interventional studies, 221 across the 324 observational. Of the 1,562 that completed or were terminated, 548 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
885 of 2,338 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 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
227 of the studies in Colorectal Neoplasms with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05141721Phase 3Seattle Project CorporationA Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer | 2027-03 |
| NCT04428905Phase 3City of Hope Medical CenterSelf-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer | 2027-03-31 |
| NCT02997228Phase 3National Cancer Institute (NCI)Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study | 2027-06-01 |
| NCT01349881Phase 3SWOG Cancer Research NetworkS0820, Adenoma and Second Primary Prevention Trial | 2027-09-15 |
| NCT03796884Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityLinaclotide in Treating Patients With Stages 0-3 Colorectal Cancer | 2026-11 |
Add all 227 to your calendar (.ics) → With an account.
Among the 2,338 studies in Colorectal Neoplasms 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 randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.
Patients were randomly assigned (1:1) to receive placebo or trilaciclib on Days 1 and 2 administered intravenously (IV) prior to FOLFOXIRI/bevacizumab in 14-day cycles for up to 12 cycles (Induction).
Following completion of Induction, patients continued in Maintenance, where they received trilaciclib or placebo per randomization allocation at study entry. Trilaciclib/placebo will be administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction. The patient continued to receive treatment on study until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation by Investigator, or the end of the trial, whichever occurs first. Treatment cycles occurred consecutively without interruption, except when necessary to manage toxicities or for administrative reasons.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During Induction the following study drugs are administered on Day 1: Irinotecan - IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil - continuous infusion (CI) over 46 to 48 hours beginning on Day 1, Bevacizumab - IV Following completion of Induction, patients will continue in Maintenance, where they will continue to receive trilaciclib per randomization allocation at study entry. Trilaciclib will be administered prior to infusional- 5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.
Drug: Trilaciclib
The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.
Drug: Placebo
Trilaciclib diluted in dextrose 5% in water or normal saline (sodium chloride solution 0.9%) administered by IV infusion over approximately 30 (±10) minutes no more than 4 hours prior to each Day 1 chemotherapy administration. Second dose of trilaciclib was administered on Day 2.
Also known as: G1T28, CDK 4/6 inhibitor
Dextrose 5% in water or normal saline (sodium chloride solution 0.9%) administered by IV infusion over 30 (±10) minutes no more than 4 hours prior to each Day 1 chemotherapy administration. Second dose of placebo was administered on Day 2.
Duration of Severe Neutropenia (DSN)
The DSN was defined as the number of days for the first severe neutropenia (SN) event in Cycles 1, 2, 3, or 4 for participants who had at least one SN event in the first 4 cycles of Induction. It was calculated as the days from the date of the first absolute neutrophil count (ANC) value of \< 0.5 × 10\^9/L to the date of the first ANC value ≥ 0.5 × 10\^9/L where no additional ANC values \< 0.5 × 10\^9/L were observed for the remainder of that cycle.
Time frame: Cycles 1 to 4 (14-day cycles up to 56 days)
Occurrence of Severe Neutropenia (SN) During Induction
Severe neutropenia was defined as the absolute neutrophil count (ANC) laboratory value that met the Common Terminology Criteria for Adverse vents (CTCAE) criteria for ≥ Grade 4 toxicity (ie, ANC \< 0.5 × 10\^9/L in SI Unit)
Time frame: Induction Period, cycles 1-12 (14-day cycles up to 168 days)
Overall Survival (OS)
Overall survival is defined as the time from the date of the first dose of study treatment to the date of death from any cause.
Time frame: Up to 52 months
Additional Myelopreservation Measures
To assess the effects of trilaciclib on additional measures of the neutrophil lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC as measured by the number of SN events, granulocyte-colony stimulating factor (G-CSF) administration and febrile neutropenia (FN) adverse events (AE)
Time frame: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Red Blood Cell Lineage
To assess the effects of trilaciclib on the red blood cell (RBC) lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 decreased hemoglobin laboratory values, RBC transfusions on or after Week 5, and erythropoiesis-stimulating agents (ESA) administration
Time frame: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Platelet Lineage
To assess the effects of trilaciclib on the platelet lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCR by measure of Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions.
Time frame: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Multiple Lineage
To assess the effects of trilaciclib on multiple lineages compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 hematologic lab values.
Time frame: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Standard of Care Dosing
To assess the effects of trilaciclib on standard of care dosing compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of all-cause dose reductions or cycle delays and relative dose intensity for FOLFOXIRI/bevacizumab
Time frame: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Healthcare Utilization
To assess the effects of trilaciclib on healthcare utilization compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of hospitalizations and antibiotic use.
Time frame: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Best Overall Response (BOR)
Best overall response (BOR) will be determined using all visit responses prior to or on the date of (i) radiographic disease progression; (ii) withdrawal of consent to obtain scans; (iii) death; (iv) lost to follow-up; or (v) initiation of subsequent anti-cancer therapy other than the study drugs, whichever is earlier will be based on RECIST v1.1.
Time frame: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference based on RECIST v1.1.
Time frame: Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks
Duration of Objective Response (DOR)
DOR is the time between first objective response of CR or PR and the first date that progressive disease is objectively documented or death, whichever comes first.
Time frame: Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization until the date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first.
Time frame: Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks
Quality of Life/ Effects on Chemotherapy-Induced Fatigue
To assess the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC, as measured by Time To First Confirmed Deterioration of Fatigue (TTCD-fatigue) during Induction, as measured by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue).
Time frame: Through Induction Period- on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Number of Participants With Reported Adverse Events to Measure Safety and Tolerability
To assess the safety and tolerability of trilaciclib compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of occurrence and severity of AEs by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, changes in laboratory parameters, vital signs and electrocardiogram (ECG) parameters, grade 3 or 4 abnormalities in chemistry laboratory parameters, and study treatment discontinuation due to AEs.
Time frame: Safety was assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks
89 study centers in 8 countries consented at least 1 participant. The first participant was enrolled on January 6, 2021 and the last visit of the last participant occurred on March 31, 2023.
| Milestone | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| Started | 164 | 162 |
| Patients with ≥ 1 dose of study drug, n (%) | 159 | 160 |
| Completed | 0 | 0 |
| Not completed | 164 | 162 |
| Withdrew: Death | 49 | 26 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Study terminated by sponsor | 92 | 114 |
| Withdrew: Withdrawal by subject | 12 | 11 |
| Withdrew: Other, unspecified | 8 | 7 |
The DSN was defined as the number of days for the first severe neutropenia (SN) event in Cycles 1, 2, 3, or 4 for participants who had at least one SN event in the first 4 cycles of Induction. It was calculated as the days from the date of the first absolute neutrophil count (ANC) value of \< 0.5 × 10\^9/L to the date of the first ANC value ≥ 0.5 × 10\^9/L where no additional ANC values \< 0.5 × 10\^9/L were observed for the remainder of that cycle.
| days | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| Duration of Severe Neutropenia (DSN) | 0.1 ± 0.84 | 1.3 ± 3.14 |
Severe neutropenia was defined as the absolute neutrophil count (ANC) laboratory value that met the Common Terminology Criteria for Adverse vents (CTCAE) criteria for ≥ Grade 4 toxicity (ie, ANC \< 0.5 × 10\^9/L in SI Unit)
| event per 100 cycles | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| Occurrence of Severe Neutropenia (SN) During Induction | 0.1 | 3 |
Overall survival is defined as the time from the date of the first dose of study treatment to the date of death from any cause.
No measurements were reported for this outcome.
To assess the effects of trilaciclib on additional measures of the neutrophil lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC as measured by the number of SN events, granulocyte-colony stimulating factor (G-CSF) administration and febrile neutropenia (FN) adverse events (AE)
No measurements were reported for this outcome.
To assess the effects of trilaciclib on the red blood cell (RBC) lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 decreased hemoglobin laboratory values, RBC transfusions on or after Week 5, and erythropoiesis-stimulating agents (ESA) administration
No measurements were reported for this outcome.
To assess the effects of trilaciclib on the platelet lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCR by measure of Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions.
No measurements were reported for this outcome.
To assess the effects of trilaciclib on multiple lineages compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 hematologic lab values.
No measurements were reported for this outcome.
To assess the effects of trilaciclib on standard of care dosing compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of all-cause dose reductions or cycle delays and relative dose intensity for FOLFOXIRI/bevacizumab
No measurements were reported for this outcome.
To assess the effects of trilaciclib on healthcare utilization compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of hospitalizations and antibiotic use.
No measurements were reported for this outcome.
Best overall response (BOR) will be determined using all visit responses prior to or on the date of (i) radiographic disease progression; (ii) withdrawal of consent to obtain scans; (iii) death; (iv) lost to follow-up; or (v) initiation of subsequent anti-cancer therapy other than the study drugs, whichever is earlier will be based on RECIST v1.1.
| percentage of participants | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| Complete response | 0 | 3 |
| Partial response | 75 | 91 |
| Stable disease | 50 | 36 |
| Progressive disease | 5 | 7 |
| Not evaluable | 7 | 3 |
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \<10 mm or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference based on RECIST v1.1.
| percentage of participants | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| Objective Response Rate (ORR) | 41.6 (33.3 to 50.3) | 57.1 (48.5 to 65.5) |
DOR is the time between first objective response of CR or PR and the first date that progressive disease is objectively documented or death, whichever comes first.
| months | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| Duration of Objective Response (DOR) | 9.1 (7.9 to 10.2) | 12.7 (9.5 to NA) |
PFS is defined as the time from the date of randomization until the date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first.
| months | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| Progression Free Survival (PFS) | 10.3 (8.6 to 11) | 13.1 (11 to 18.5) |
To assess the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC, as measured by Time To First Confirmed Deterioration of Fatigue (TTCD-fatigue) during Induction, as measured by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue).
No measurements were reported for this outcome.
To assess the safety and tolerability of trilaciclib compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of occurrence and severity of AEs by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, changes in laboratory parameters, vital signs and electrocardiogram (ECG) parameters, grade 3 or 4 abnormalities in chemistry laboratory parameters, and study treatment discontinuation due to AEs.
| Participants | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| Number of patients with any AE | 157 | 159 |
| Number of patients with any AE of CTCAE Grade ≥ 3 | 106 | 117 |
| Number of patients with any AE of CTCAE Grade ≥ 4 | 18 | 35 |
| Number of patients with any study drug-related AE | 154 | 155 |
| Trilaciclib/Placebo-Related AE | 109 | 103 |
| Fluorouracil-related AE | 139 | 151 |
| Leucovorin-related AE | 103 | 122 |
| Oxaliplatin-related AE | 143 | 151 |
| Irinotecan-related AE | 143 | 151 |
| Bevacizumab-related AE | 127 | 128 |
| Patients with any serious AE | 47 | 47 |
| Patients with AE leading to discontinuation of any study drug | 50 | 47 |
| Leading to trilaciclib/placebo discontinuation | 19 | 13 |
| Leading to fluorouracil discontinuation | 19 | 14 |
| Leading to leucovorin discontinuation | 20 | 13 |
| Leading to oxaliplatin discontinuation | 38 | 30 |
| Leading to irinotecan discontinuation | 20 | 20 |
| Leading to bevacizumab discontinuation | 31 | 26 |
| Patients with trilaciclib/placebo-related AE leading to discontinuation of any study drug | 10 | 9 |
| Patients with AE leading to death | 8 | 3 |
| Patients with AESI for trilaciclib | 33 | 28 |
Collected over Safety was assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trilaciclib + FOLFOXIRI/Bevacizumab | 49/159 (30.8%) | 47/159 (29.6%) | 155/159 (97.5%) |
| Placebo + FOLFOXIRI/Bevacizumab | 26/160 (16.3%) | 47/160 (29.4%) | 159/160 (99.4%) |
| Event | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 0/159 | 5/160 |
| NeutropeniaBlood and lymphatic system disorders | 0/159 | 5/160 |
| Intestinal obstructionGastrointestinal disorders | 4/159 | 3/160 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 4/159 | 4/160 |
| VomitingGastrointestinal disorders | 3/159 | 2/160 |
| PneumoniaInfections and infestations | 3/159 | 1/160 |
| Abdominal painGastrointestinal disorders | 1/159 | 3/160 |
| DiarrhoeaGastrointestinal disorders | 2/159 | 3/160 |
| PyrexiaGeneral disorders | 1/159 | 3/160 |
| SepsisInfections and infestations | 1/159 | 3/160 |
| Event | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 83/159 | 118/160 |
| NauseaGastrointestinal disorders | 85/159 | 101/160 |
| NeutropeniaBlood and lymphatic system disorders | 61/159 | 92/160 |
| VomitingGastrointestinal disorders | 54/159 | 64/160 |
| AnaemiaBlood and lymphatic system disorders | 57/159 | 61/160 |
| FatigueGeneral disorders | 53/159 | 52/160 |
| StomatitisGastrointestinal disorders | 25/159 | 42/160 |
| Decreased appetiteMetabolism and nutrition disorders | 36/159 | 39/160 |
| ConstipationGastrointestinal disorders | 38/159 | 29/160 |
| Peripheral sensory neuropathyNervous system disorders | 37/159 | 34/160 |
Information presented is based on overall enrollment into the study and constitutes the ITT population.
| Age, Continuous(Years) | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab | Total |
|---|---|---|---|
| Mean | 56.2 ± 11.80 | 55.5 ± 10.60 | 55.8 ± 11.21 |
| Sex: Female, Male(Participants) | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab | Total |
|---|---|---|---|
| Female | 58 | 61 | 119 |
| Male | 106 | 101 | 207 |
| Race/Ethnicity, Customized(Participants) | Trilaciclib + FOLFOXIRI/Bevacizumab | Placebo + FOLFOXIRI/Bevacizumab | Total |
|---|---|---|---|
| White | 119 | 112 | 231 |
| Black or African American | 4 | 9 | 13 |
| Asian | 32 | 33 | 65 |
| Other | 3 | 0 | 3 |
| Not Reported | 3 | 3 | 6 |
| Unknown | 3 | 5 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Feb 2023, 25 months.
Results were first posted in Nov 2024, 1 year 9 months after primary completion.
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Studies of the drug tested here: Trilaciclib