TOPARP: A Phase II Trial of Olaparib in Patients With Advanced Castration Resistant Prostate Cancer

Conditions

• Adenocarcinoma of the Prostate

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olaparib — DRUG
  Until objective disease progression, unacceptable toxicity or patient withdrawal for whatever reason

Study Details

This is an open-label, single arm, two part adaptive design phase II trial of Olaparib in patients with advanced castration resistant prostate cancer. The trial aims to evaluate the the anti-tumour activity of Olaparib in metastatic castration resistant prostate cancer, identify molecular signatures of tumour cells in responding and non-responding patients, and to identify predictive biomarkers of Olaparib response.

Key Dates

Start date

Jul 31, 2012

Status verified

Aug 2019

Primary completion

Mar 31, 2019

Completion

Feb 29, 2020

Study Design

Enrollment

148 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Olaparib 400mg
  Oral Olaparib at a dose of 400mg twice daily, continuously on a 28 day cycle
• Experimental: Olaparib 300mg
  Oral Olaparib at a dose of 300mg twice daily, continuously on a 28 day cycle

Primary Outcome Measure

Response rate to Olaparib [ Time Frame: Response will be evaluated 6 months post trial entry ]