A Phase 2 interventional study of Onvansertib and Abiraterone in Metastatic Castration-Resistant Prostate Cancer, sponsored by Cardiff Oncology. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Cardiff Oncology · Phase 2, Interventional, and Treatment
The purpose of the phase 2 study is to determine whether Onvansertib is safe and tolerable in adult participants with Metastatic Castration-Resistant Prostate Cancer who have disease progression while receiving abiraterone acetate (abiraterone) and prednisone therapy, and to observe the effects of Onvansertib in combination with abiraterone and prednisone on disease control.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Cardiff Oncology is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Participant has been on abiraterone for castration-sensitive prostate cancer (CSPC) or castration-resistant prostate cancer (CRPC). Participants who have received abiraterone for CSPC must have had a response to hormonal therapy, as defined by any decline in PSA, radiographic response and/or clinical benefit after starting hormonal therapy.
Participants who have received abiraterone for CRPC must have responded to abiraterone, defined by any decline in PSA, radiographic response, and/or clinical benefit after starting abiraterone.
Participant has adequate bone marrow and organ function as shown by:
Exclusion Criteria:
Use of any chemotherapy, agents, immunotherapy, or hormonal therapy other than GnRH agonists within 28 days of the start of treatment on protocol.
Use of bone targeted agents including bisphosphonates and RANK ligand inhibitors is allowed if on stable dose; Xgeva or Zometa cannot be started within 28 days of initiating study therapy.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 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.
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 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.
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.
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.
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.
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.
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone. This arm was discontinued.
Drug: Onvansertib · Drug: Abiraterone · Drug: Prednisone
On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone.
Drug: Onvansertib · Drug: Abiraterone · Drug: Prednisone
On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone.
Drug: Onvansertib · Drug: Abiraterone · Drug: Prednisone
Onvansertib orally
Also known as: PCM-075
Abiraterone orally
Prednisone orally
Percentage of Participants Achieving Disease Control at or Before 12 Weeks
Disease control was defined as lack of prostate-specific antigen (PSA) progression per Prostate Cancer Working Group 3 (PCWG3) criteria: not having an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL during the first 12 weeks of PSA assessments. Participants that do not have 12 weeks of PSA assessments were considered not to have demonstrated PSA progression control in this analysis. If a participant achieved disease control prior to Week 12, but relapsed at, or before Week 12, disease control was still considered achieved. The 90% confidence intervals were calculated using Wilson Confidence Interval.
Time frame: Baseline up to Week 12
Mean Percentage Change From Baseline in PSA at 12 Weeks
PSA level was measured via blood sample. Mean and standard deviation change is reported.
Time frame: Baseline and Week 12
Mean Absolute Change From Baseline in PSA at 12 Weeks
PSA level was measured via blood sample. Mean and standard deviation change is reported.
Time frame: Baseline and Week 12
Median Percentage Change From Baseline in PSA at 12 Weeks
PSA level was measured via blood sample. Median, minimum and maximum change is reported.
Time frame: Baseline and Week 12
Median Absolute Change From Baseline in PSA at 12 Weeks
PSA level was measured via blood sample. Median, minimum and maximum change is reported.
Time frame: Baseline and Week 12
Time to PSA Progression or Death
Time to PSA progression in weeks is defined as time from Cycle 1 Day 1 (initiation of treatment) until initiation of any PSA progression per PCWG3 criteria: an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL. If a participant discontinued from the study without confirmed PSA progression or death, then they were censored at the last PSA laboratory date. Kaplan-Meier method was used.
Time frame: Up to approximately 100 weeks
Time to Radiographic Progression or Death
Time to radiographic progression in weeks is defined as time from Cycle 1 Day 1 (initiation of treatment) until initiation of any radiographic progression per PCWG3 criteria. If a participant discontinued from the study without confirmed radiographic progression or death, then they were censored at the last valid assessment date.
Time frame: Up to approximately 110 weeks
Percentage of Participants Achieving Radiographic Responses at or Before 12 Weeks
Radiographic response is defined as the best overall response between Cycle 1 Day 1 and 12 weeks post-baseline being stable disease (SD) or better (partial response \[PR\] or complete response \[CR\]) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1): CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Time frame: Baseline up to Week 12
Percentage of Participants Who Are Adherent to Study Treatment (PP Analysis) Achieving Disease Control at or Before 12 Weeks
Disease control was defined as lack of PSA progression per PCWG3 criteria: not having an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL during the first 12 weeks of PSA assessments. Participants that do not have 12 weeks of PSA assessments were considered not to have demonstrated PSA progression control in this analysis. If a participant achieved disease control prior to Week 12, but relapsed at, or before Week 12, disease control was still considered achieved. The 90% confidence intervals were calculated using Wilson Confidence Interval.
Time frame: Baseline up to Week 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse events (AEs) are defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs are defined as AEs with a start date after Cycle 1 Day 1. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 on a scale from Grade 1 (mild) to Grade 5 (death related to AE).
Time frame: Up to approximately 27 months
Number of Participants With DLTs
DLTs are defined as a CTCAE Grade 4 hematologic AE or CTCAE Grade ≥ 3 non-hematologic AE that is considered related to the study drug.
Time frame: Arms A and B: up to one 21-day cycle; Arm C: up to two 14-day cycles
A total of 72 participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) were enrolled at 3 investigative sites in the United States between August 2018 and October 2023. Arm A was discontinued with Protocol Version 1.6 (08 Nov 2019). Any participants enrolled and were continuing treatment in Arm A had the opportunity to transition to Arm B (with a re-consent) at the start of their next cycle and at the discretion of the Investigator.
| Milestone | Arm A: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|
| Started | 24 | 20 | 28 |
| Transferred to arm b | 2 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 24 | 20 | 28 |
| Withdrew: Adverse event | 6 | 1 | 1 |
| Withdrew: Death | 0 | 0 | 1 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 1 |
| Withdrew: Physician decision | 1 | 3 | 2 |
| Withdrew: Withdrawal of informed consent | 2 | 1 | 4 |
| Withdrew: Progressive disease | 15 | 15 | 17 |
| Withdrew: Miscellaneous | 0 | 0 | 2 |
Disease control was defined as lack of prostate-specific antigen (PSA) progression per Prostate Cancer Working Group 3 (PCWG3) criteria: not having an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL during the first 12 weeks of PSA assessments. Participants that do not have 12 weeks of PSA assessments were considered not to have demonstrated PSA progression control in this analysis. If a participant achieved disease control prior to Week 12, but relapsed at, or before Week 12, disease control was still considered achieved. The 90% confidence intervals were calculated using Wilson Confidence Interval.
| percentage of participants | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone | Total |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Disease Control at or Before 12 Weeks | 13.6 (5.6 to 29.7) | 50.0 (12.1 to 87.9) | 35.0 (20.2 to 53.3) | 35.7 (22.7 to 51.3) | 29.2 (21.2 to 38.6) |
PSA level was measured via blood sample. Mean and standard deviation change is reported.
| percentage of PSA | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Mean Percentage Change From Baseline in PSA at 12 Weeks | 84.330 ± 52.545 | 67.064 ± 50.350 | 42.661 ± 60.818 | 77.675 ± 94.611 |
PSA level was measured via blood sample. Mean and standard deviation change is reported.
| ng/mL | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Mean Absolute Change From Baseline in PSA at 12 Weeks | 10.904 ± 10.141 | 3.095 ± 2.199 | 14.971 ± 45.023 | 7.295 ± 13.076 |
PSA level was measured via blood sample. Median, minimum and maximum change is reported.
| percentage of PSA | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Median Percentage Change From Baseline in PSA at 12 Weeks | 94.814 (8.443 to 155.720) | 67.064 (31.461 to 102.667) | 25.828 (-65.823 to 137.069) | 54.630 (-31.414 to 401.348) |
PSA level was measured via blood sample. Median, minimum and maximum change is reported.
| ng/mL | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Median Absolute Change From Baseline in PSA at 12 Weeks | 9.110 (0.19 to 26.00) | 3.095 (1.54 to 4.65) | 1.345 (-20.80 to 155.00) | 2.300 (-5.73 to 47.64) |
Time to PSA progression in weeks is defined as time from Cycle 1 Day 1 (initiation of treatment) until initiation of any PSA progression per PCWG3 criteria: an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL. If a participant discontinued from the study without confirmed PSA progression or death, then they were censored at the last PSA laboratory date. Kaplan-Meier method was used.
| weeks | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Time to PSA Progression or Death | 5.1 (3.0 to 9.0) | 10.5 (3.0 to NA) | 10.9 (4.0 to 18.0) | 9.0 (8.0 to 18.0) |
Time to radiographic progression in weeks is defined as time from Cycle 1 Day 1 (initiation of treatment) until initiation of any radiographic progression per PCWG3 criteria. If a participant discontinued from the study without confirmed radiographic progression or death, then they were censored at the last valid assessment date.
| weeks | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Time to Radiographic Progression or Death | 12.0 (8.6 to NA) | NA (NA to NA) | 17.4 (3.9 to NA) | 57.0 (19.1 to 96.1) |
Radiographic response is defined as the best overall response between Cycle 1 Day 1 and 12 weeks post-baseline being stable disease (SD) or better (partial response \[PR\] or complete response \[CR\]) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1): CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
| percentage of participants | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Percentage of Participants Achieving Radiographic Responses at or Before 12 Weeks | 28.6 (10.0 to 59.1) | — | 62.5 (34.8 to 83.9) | 80.0 (54.1 to 93.1) |
Disease control was defined as lack of PSA progression per PCWG3 criteria: not having an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL during the first 12 weeks of PSA assessments. Participants that do not have 12 weeks of PSA assessments were considered not to have demonstrated PSA progression control in this analysis. If a participant achieved disease control prior to Week 12, but relapsed at, or before Week 12, disease control was still considered achieved. The 90% confidence intervals were calculated using Wilson Confidence Interval.
| percentage of participants | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Percentage of Participants Who Are Adherent to Study Treatment (PP Analysis) Achieving Disease Control at or Before 12 Weeks | 13.3 (4.5 to 33.4) | 50.0 (12.1 to 87.9) | 38.9 (22.7 to 58.0) | 36.0 (22.3 to 52.4) |
Adverse events (AEs) are defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs are defined as AEs with a start date after Cycle 1 Day 1. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 on a scale from Grade 1 (mild) to Grade 5 (death related to AE).
| Participants | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Any TEAEs | 22 | 2 | 20 | 27 |
| Any TEAEs with CTCAE Grade ≥3 | 12 | 0 | 11 | 13 |
DLTs are defined as a CTCAE Grade 4 hematologic AE or CTCAE Grade ≥ 3 non-hematologic AE that is considered related to the study drug.
| Participants | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| Number of Participants With DLTs | 4 | 0 | 4 | 3 |
Collected over Up to approximately 27 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Onvansertib + Abiraterone and Prednisone | 0/22 (0%) | 5/22 (22.7%) | 21/22 (95.5%) |
| Arm A to B: Onvansertib + Abiraterone and Prednisone | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Arm B: Onvansertib + Abiraterone and Prednisone | 0/20 (0%) | 5/20 (25%) | 20/20 (100%) |
| Arm C: Onvansertib + Abiraterone and Prednisone | 2/28 (7.1%) | 6/28 (21.4%) | 27/28 (96.4%) |
| Event | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| SepsisInfections and infestations | 0/22 | 0/2 | 0/20 | 3/28 |
| Enterocolitis infectiousInfections and infestations | 0/22 | 0/2 | 1/20 | 0/28 |
| PneumoniaInfections and infestations | 0/22 | 0/2 | 1/20 | 0/28 |
| NeutropeniaBlood and lymphatic system disorders | 1/22 | 0/2 | 1/20 | 0/28 |
| Dental cariesGastrointestinal disorders | 0/22 | 0/2 | 1/20 | 0/28 |
| PainGeneral disorders | 0/22 | 0/2 | 1/20 | 1/28 |
| PyrexiaGeneral disorders | 0/22 | 0/2 | 1/20 | 0/28 |
| DizzinessNervous system disorders | 0/22 | 0/2 | 1/20 | 0/28 |
| Myocardial infarctionCardiac disorders | 0/22 | 0/2 | 1/20 | 0/28 |
| Soft tissue infectionInfections and infestations | 1/22 | 0/2 | 0/20 | 0/28 |
| Event | Arm A: Onvansertib + Abiraterone and Prednisone | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone |
|---|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 12/22 | 0/2 | 5/20 | 5/28 |
| AnaemiaBlood and lymphatic system disorders | 8/22 | 1/2 | 8/20 | 12/28 |
| FatigueGeneral disorders | 11/22 | 1/2 | 6/20 | 10/28 |
| HypophosphataemiaMetabolism and nutrition disorders | 3/22 | 1/2 | 9/20 | 7/28 |
| Back painMusculoskeletal and connective tissue disorders | 3/22 | 1/2 | 2/20 | 4/28 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 2/22 | 1/2 | 2/20 | 2/28 |
| Musculoskeletal chest painMusculoskeletal and connective tissue disorders | 0/22 | 1/2 | 0/20 | 2/28 |
| NauseaGastrointestinal disorders | 2/22 | 1/2 | 2/20 | 5/28 |
| Abdominal painGastrointestinal disorders | 0/22 | 1/2 | 0/20 | 0/28 |
| Fungal skin infectionInfections and infestations | 0/22 | 1/2 | 0/20 | 0/28 |
Safety Population: comprises all participants who received any dose of onvansertib.
| Age, Continuous(years) | Arm A: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone | Total |
|---|---|---|---|---|
| Mean | 70.7 ± 7.44 | 71.3 ± 8.39 | 69.4 ± 9.12 | 70.4 ± 8.31 |
| Sex: Female, Male(Participants) | Arm A: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 24 | 20 | 28 | 72 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 | 2 |
| Not Hispanic or Latino | 20 | 16 | 25 | 61 |
| Unknown or Not Reported | 4 | 3 | 2 | 9 |
| Race/Ethnicity, Customized(Participants) | Arm A: Onvansertib + Abiraterone and Prednisone | Arm B: Onvansertib + Abiraterone and Prednisone | Arm C: Onvansertib + Abiraterone and Prednisone | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Black or African American | 0 | 3 | 2 | 5 |
| Native Hawaiian or Pacific Islander | 0 | 0 | 0 | 0 |
| White | 24 | 17 | 23 | 64 |
| Other | 0 | 0 | 1 | 1 |
| Unknown | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Onvansertib
Cardiff Oncology