Phase 2
Completed N=72
Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov NCT03414034 ↗Enrolled (actual)
72
Serious AEs
22.2%
Results posted
Nov 2024
Primary outcomePrimary: Percentage of Participants Achieving Disease Control at or Before 12 Weeks — 13.6; 50.0; 35.0; 35.7 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Disease Control at or Before 12 Weeks |
13.6; 50.0; 35.0; 35.7; 29.2 | — |
| SECONDARY Mean Percentage Change From Baseline in PSA at 12 Weeks |
84.330; 67.064; 42.661; 77.675 | — |
| SECONDARY Mean Absolute Change From Baseline in PSA at 12 Weeks |
10.904; 3.095; 14.971; 7.295 | — |
| SECONDARY Median Percentage Change From Baseline in PSA at 12 Weeks |
94.814; 67.064; 25.828; 54.630 | — |
| SECONDARY Median Absolute Change From Baseline in PSA at 12 Weeks |
9.110; 3.095; 1.345; 2.300 | — |
| SECONDARY Time to PSA Progression or Death |
5.1; 10.5; 10.9; 9.0 | — |
| SECONDARY Time to Radiographic Progression or Death |
12.0; NA; 17.4; 57.0 | — |
| SECONDARY Percentage of Participants Achieving Radiographic Responses at or Before 12 Weeks |
28.6; 62.5; 80.0 | — |
| SECONDARY Percentage of Participants Who Are Adherent to Study Treatment (PP Analysis) Achieving Disease Control at or Before 12 Weeks |
13.3; 50.0; 38.9; 36.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
22; 2; 20; 27; 12; 0 | — |
| SECONDARY Number of Participants With DLTs |
4; 0; 4; 3 | — |
Eligibility Criteria
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT03414034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.