AZ D081DC00008 Metastatic Castrate-Resistant Prostate Cancer

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel

• IRAS ID

  141905

• Contact name

  Noel Clarke

• Contact email

  noel.clarke@christie.nhs.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2013-003520-37

• Clinicaltrials.gov Identifier

  NCT01972217

• Research summary

  Research Summary:
  This is a 2-part study for males aged 18 years or older with metastatic (spreading to other parts of the body) castrate-resistant (disease progressing despite low testosterone levels) prostate cancer who have previously been treated with chemotherapy with Docetaxel (well established chemotherapy medication).

  Part A will assess the safest and most tolerable dose of Olaparib (study drug) for participants to take when it’s given in addition to Abiraterone (hormone therapy to stop the production of testosterone). This part will be split into 2 cohorts; cohort 1 (up to 6 participants) will assess a 200mg, twice-daily dose of Olaparib with a once-daily 1000mg dose of Abiraterone. If this dose can be tolerated, cohort 2 (12 participants) will assess a 300mg, twice-daily dose of Olaparib with a once-daily 1000mg dose of Abiraterone. However, if there are 4 or more dose-limiting toxicities in cohort 2, then a third cohort (12 participants) will be used to assess a 200mg, twice-daily dose of Olaparib with a once-daily 1000mg dose of Abiraterone. If there are 4 or more dose-limiting toxicities in cohort 3 then the study will be stopped.

  Once the most suitable dose has been established in part A, part B will assess how effective Olaparib is when given in addition to Abiraterone compared with a placebo (identical to Olaparib in appearance but contains no active drug) in addition to Abiraterone.

  For part A, between 15 - 18 participants shall be enrolled globally but not all countries will be involved. For part B, approximately 140 participants will be enrolled. Participants enrolled in part A are excluded from participating in part B.

  Summary of Results:
  Please reference URL:
  Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer. - Study Results - ClinicalTrials.gov

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  13/SC/0635

• Date of REC Opinion

  4 Feb 2014

• REC opinion

  Further Information Favourable Opinion