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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 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 158 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01972217
The ClinicalTrials.gov registry entry for NCT01972217 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01972217 reports 0 study locations.
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.
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