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Steroid Hormone Biosynthesis Inhibitor
Olaparib + Abiraterone for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomisation until analysis cut-off date (up to approximately 3 years).
Awards & highlights
Study Summary
This trial is testing the safety and efficacy of adding olaparib to abiraterone for the treatment of metastatic castration-resistant prostate cancer.
Eligible Conditions
- Metastatic Castration Resistant Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomisation until analysis cut-off date (up to approximately 3 years).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomisation until analysis cut-off date (up to approximately 3 years).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Number of Patients With Dose Limiting Toxicities (DLTs)
Part A: Percentage of Patients Experiencing Adverse Events (AEs)
Part B: Median Radiological Progression-Free Survival (rPFS) Time
+1 moreSecondary outcome measures
Therapeutic procedure
Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)
Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss)
+13 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: OlaparibActive Control3 Interventions
200 mg or 300 mg bid
Group II: PlaceboPlacebo Group3 Interventions
placebo to match olaparib bid
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,907 Previous Clinical Trials
5,065,938 Total Patients Enrolled
28 Trials studying Prostate Cancer
17,397 Patients Enrolled for Prostate Cancer
AstraZenecaLead Sponsor
4,287 Previous Clinical Trials
288,619,992 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,522 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received immunotherapy or radium-223 for treating advanced prostate cancer in the past.You have taken strong medications that can either slow down or speed up the breakdown of other drugs in your body within the past 2 weeks (3 weeks for St. John's Wort).You have tumors in your spine or brain, but if they are not causing symptoms, treated and stable for at least 4 weeks without needing steroids, you can still participate in the study.You have already received more than two rounds of chemotherapy for advanced prostate cancer.You should not have any ongoing side effects from previous treatments that are worse than a moderate level, except for hair loss or side effects caused by certain medications.You have had another type of cancer in the past 5 years, except for non-melanoma skin cancer or other solid tumors that have been successfully treated and have not returned for at least 5 years.I'm sorry, but I need more information to rewrite this criterion. Could you please provide the specific treatments that are listed in the original criterion?You have received a medicine called a PARP inhibitor, like olaparib, in the past.You have received a bone marrow transplant from someone else in the past.You have ongoing problems with severe nausea and vomiting or chronic gastrointestinal diseases. You also have difficulty swallowing the study medication or have had a significant portion of your bowel removed, which could affect how your body absorbs the medication.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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