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NCT03414034 · ClinicalTrials.gov registry record · Phase 2
Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Cardiff Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 3
- Study locations
NCT03414034: Completed Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Cardiff Oncology.
NCT03414034 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer that has completed, run by Cardiff Oncology. The registered enrollment target is 72 participants, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (63% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03414034, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, has completed, sponsored by Cardiff Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG Abiraterone
- DRUG Onvansertib
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-08-14 |
| Est. Completion | 2023-10-16 |
| Phase | Phase 2 |
What the finished NCT03414034 record still lists
NCT03414034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Prednisone is the first listed.
NCT03414034 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03414034 about?
NCT03414034 is a clinical study titled "Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer". 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 O...
What is the current status of trial NCT03414034?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2018-08-14. Estimated completion is 2023-10-16.
What conditions does trial NCT03414034 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT03414034?
The interventions under investigation include: Prednisone (DRUG), Abiraterone (DRUG), Onvansertib (DRUG).
Who is sponsoring clinical trial NCT03414034?
This trial is sponsored by Cardiff Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03414034 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03414034's enrollment target sits among peer trials
72 35th of 69 higher than 35 of 69 other Metastatic Castration-Resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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