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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 weeks
Treatment ~ Varies
Follow Up ~from randomisation until analysis cut-off date (up to approximately 3 years).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation until analysis cut-off date (up to approximately 3 years). for reporting.

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 more
Secondary 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 more

Trial 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

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,395 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,997 Patients Enrolled for Prostate Cancer
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,744 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,522 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone (Steroid Hormone Biosynthesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01972217 — Phase 2
Prostate Cancer Research Study Groups: Olaparib, Placebo
Prostate Cancer Clinical Trial 2023: Abiraterone Highlights & Side Effects. Trial Name: NCT01972217 — Phase 2
Abiraterone (Steroid Hormone Biosynthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01972217 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this experiment limit participation to individuals under 80 years of age?

"This study will only accept patients between the ages of 18 and 130. Separately, there are 162 trials for minors and 1767 studies open to those over 65 years old."

Answered by AI

Has Olaparib been granted authorization by the FDA?

"For the safety of Olaparib, our team has assigned a score of 2. This is because Phase 2 trials have provided some evidence that this drug is safe, yet there are no studies confirming its efficacy."

Answered by AI

What aims are investigators hoping to accomplish with this experiment?

"The primary purpose of the trial is to assess how many patients experience dose-limiting toxicities, while secondary objectives include determining the percentage of patients with PSA responses, assessing anti-tumour activity through CTC levels and calculating abiraterone tmax,ss following multiple dosing."

Answered by AI

What therapeutic applications does Olaparib have?

"Olaparib is primarily utilized for treating multiple sclerosis, but it can be prescribed to manage a range of other medical issues including ulcerative colitis, varicella-zoster virus acute retinal necrosis and brain."

Answered by AI

Are there currently any vacancies for this medical research project?

"According to the data supplied by clinicaltrials.gov, this medical trial has ceased recruiting patients after being initially posted on April 1st 2014 and last updated October 7th 2022. Fortunately there are 1852 other trials with open enrolment at present."

Answered by AI

Do I meet the qualifications necessary to participate in this medical experiment?

"This medical trial seeks 158 male participants aged 18 to 130 who have undergone castration and are diagnosed with prostate cancer. To be eligible, applicants must exhibit an Eastern Cooperative Oncology Group performance status of 0-2 over the last fortnight, possess a life expectancy ≥12 weeks, remain on stable concomitant medications (except for bisphosphonates, denosumab and corticosteroids) , agree to follow protocol instructions throughout their participation in the study including undergoing treatment & examinations and completing PRO instruments., For those selected to partake in the randomized phase only, prior docetaxel chemotherapy is required. However patients who discontinued"

Answered by AI

What other investigations have been conducted relative to Olaparib?

"Currently, there are 599 active trials investigating the impact of Olaparib. A significant portion (145) have progressed to Phase 3 and Duarte, California is host to a major concentration of studies. In total, 26594 sites around the world are researching this drug's potential applications."

Answered by AI

What is the participant capacity for this research endeavor?

"As of this moment, no further participants are being accepted into the trial. This study was posted on April 1st 2014 and revised October 7th 2022. If you're seeking out other studies related to castration there are 1253 active trials while Olaparib is featured in 599 clinical studies currently recruiting patients."

Answered by AI

What is the current number of hospitals conducting this experiment?

"At the present time, 5 sites are offering this trial. Patients may choose from San Diego, London, and Greenfield Park along with other nearby centres to reduce travel-related burden associated with participation."

Answered by AI
~14 spots leftby Apr 2025