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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1208-1579 | Registry Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: onvansertib + abiraterone and prednisone | Experimental | 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. |
|
| Arm B: onvansertib + abiraterone and prednisone | Experimental | 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. |
|
| Arm C: onvansertib + abiraterone and prednisone | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onvansertib | Drug | Onvansertib orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Change From Baseline in PSA at 12 Weeks | PSA level was measured via blood sample. Mean and standard deviation change is reported. | Baseline and Week 12 |
| Mean Absolute Change From Baseline in PSA at 12 Weeks |
Not provided
Inclusion Criteria:
Males ≥ 18 years of age on the day of consenting to the study.
Ability to swallow the study drug as a whole tablet.
Histologically confirmed prostate adenocarcinoma without significant small- cell/neuroendocrine or other variant histologies, with rising PSA and/or radiographic progression in the setting of castration-level testosterone (< 50 ng/dL) indicating mCRPC. Participants must have either undergone surgical castration or continue on GnRH agonist/antagonist on the appropriate schedule throughout the study period.
Asymptomatic or minimally symptomatic disease.
Metastatic disease by bone scan or other nodal or visceral lesions on CT or MRI at any time (past or present).
Participant currently receiving abiraterone and prednisone for CRPC.
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.
Two rising PSA values separated by at least 1 week, one showing a rise of at least 0.3 ng/mL and one confirmatory value not showing a decline, while on abiraterone therapy.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Participant has adequate bone marrow and organ function as shown by:
Exclusion Criteria:
Major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery.
Rapidly progressive symptoms of mCRPC.
Acute neurological dysfunction as a result of bone metastasis.
Previously treated with enzalutamide or experimental therapies directed against androgen receptor (ie, apalutamide).
Use of any chemotherapy, investigational 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.
Systemic corticosteroids except as part of on label treatment prostate cancer regimens. Note: Topical applications (eg, rash), inhaled sprays (eg, obstructive airways diseases), eye drops or local injections (eg, intra-articular) are allowed.
Treatment with any of the drugs listed in Section 8.4.5 at the time of study treatment initiation.
Has received wide field radiotherapy (including therapeutic radioisotopes such as radium 223) ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug or has not recovered from side effects of such therapy.
New York Heart Association (NYHA) Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition.
Myocardial infarction in the previous 12 weeks (from the start of treatment)
QT interval with Fridericia's correction [QTcF] >470 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during screening and that result may be used to determine eligibility.
Planned concomitant use of medications known to prolong the QT/QTc interval
Presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34646387 | Derived | Hagege A, Ambrosetti D, Boyer J, Bozec A, Doyen J, Chamorey E, He X, Bourget I, Rousset J, Saada E, Rastoin O, Parola J, Luciano F, Cao Y, Pages G, Dufies M. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy. Theranostics. 2021 Sep 21;11(19):9571-9586. doi: 10.7150/thno.61711. eCollection 2021. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was 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 also received abiraterone and prednisone. This arm was discontinued. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2020 | Oct 3, 2024 |
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|
| Abiraterone | Drug | Abiraterone orally |
|
| Prednisone | Drug | Prednisone orally |
|
PSA level was measured via blood sample. Mean and standard deviation change is reported.
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | Arms A and B: up to one 21-day cycle; Arm C: up to two 14-day cycles |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| FG001 |
| Arm B: Onvansertib + Abiraterone and Prednisone |
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following dose limiting toxicity (DLT), the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| FG002 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
| Transferred to Arm B |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: comprises all participants who received any dose of onvansertib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. This arm was discontinued. |
| BG001 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| BG002 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Efficacy Population: comprises all participants who received at least 1 dose of onvansertib at the final recommended dose according to their arm assignments. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to Week 12 |
|
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change From Baseline in PSA at 12 Weeks | PSA level was measured via blood sample. Mean and standard deviation change is reported. | 100% Per-protocol (PP) Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. If a participant did not have a Week 12 (+/- 3 days) PSA measure, then they are not included in this analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Mean | Standard Deviation | percentage of PSA | Baseline and Week 12 |
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| Secondary | Mean Absolute Change From Baseline in PSA at 12 Weeks | PSA level was measured via blood sample. Mean and standard deviation change is reported. | 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. If a participant did not have a Week 12 (+/- 3 days) PSA measure, then they are not included in this analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 12 |
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| Secondary | Median Percentage Change From Baseline in PSA at 12 Weeks | PSA level was measured via blood sample. Median, minimum and maximum change is reported. | 100% Per-protocol (PP) Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. If a participant did not have a Week 12 (+/- 3 days) PSA measure, then they are not included in this analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Median | Full Range | percentage of PSA | Baseline and Week 12 |
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| Secondary | Median Absolute Change From Baseline in PSA at 12 Weeks | PSA level was measured via blood sample. Median, minimum and maximum change is reported. | 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. If a participant did not have a Week 12 (+/- 3 days) PSA measure, then they are not included in this analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Median | Full Range | ng/mL | Baseline and Week 12 |
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| Secondary | 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. | 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. Only participants with available data are included in the analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 100 weeks |
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| Secondary | 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. | 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. Only participants with target or non-target lesions at Baseline are included in the analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 110 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. Only participants with target or non-target lesions at Baseline and at least 1 post-baseline assessment are included. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. Only participants with available data are included in the analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Count of Participants | Participants | Up to approximately 27 months |
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| Secondary | 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. | Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately. | Posted | Count of Participants | Participants | Arms A and B: up to one 21-day cycle; Arm C: up to two 14-day cycles |
|
Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. This arm was discontinued. | 0 | 22 | 5 | 22 | 21 | 22 |
| EG001 | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. | 0 | 20 | 5 | 20 | 20 | 20 |
| EG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. | 2 | 28 | 6 | 28 | 27 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Eyelid infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bronchial wall thickening | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vasculitic rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Sherman, Head of Clinical Operations | Cardiff Oncology | 858-952-7570 | clinops@cardiffoncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2023 | Oct 3, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000706408 | onvansertib |
| C089740 | abiraterone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| Other |
|
| Unknown |
|
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|
| OG001 | Arm A to B: Onvansertib + Abiraterone and Prednisone | Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|
| OG002 | Arm B: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. |
| OG003 | Arm C: Onvansertib + Abiraterone and Prednisone | On Day 1 of each cycle, onvansertib was administered PO, 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 also received abiraterone and prednisone. |
|
|