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NCT01972217 · ClinicalTrials.gov registry record · Phase 2
Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 158
- Enrollment target
NCT01972217: Completed Phase 2 study, sponsored by AstraZeneca.
NCT01972217 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 158 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01972217, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 158 participants
- Enrollment target
Study Summary
This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.
Primary Outcome
The safety and tolerability of olaparib in combination with abiraterone was assessed during Part A of the study. The percentage of patients experiencing AEs, including information on seriousness, severity, study treatment relationship and those leading to discontinuation for all doses of olaparib and for abiraterone are presented. Severity of AEs was assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v4.0. AEs were assigned to a Grade from
Interventions
- DRUG Placebo
- DRUG Olaparib
- DRUG Abiraterone
- DRUG Prednisone or prednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2014-04-01 |
| Est. Completion | 2023-08-24 |
| Phase | Phase 2 |
What the finished NCT01972217 record still lists
NCT01972217 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01972217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01972217 about?
NCT01972217 is a clinical study titled "Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.". This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison ...
What is the current status of trial NCT01972217?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 158 participants. The study started on 2014-04-01. Estimated completion is 2023-08-24.
What interventions are being tested in trial NCT01972217?
The interventions under investigation include: Placebo (DRUG), Olaparib (DRUG), Abiraterone (DRUG), Prednisone or prednisolone (DRUG).
Who is sponsoring clinical trial NCT01972217?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01972217's enrollment target sits among peer trials
158 443rd of 2000 higher than 1,558 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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