NCT01682772

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients with advanced castration resistant prostate cancer will receive single agent Olaparib at a dose of 400mg twice daily, continuously on a 28 day cycle. Olaparib will be administered until objective disease progression or unacceptable toxicity or patient withdrawal for whatever reason

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	Olaparib	Until objective disease progression, unacceptable toxicity or patient withdrawal for whatever reason

Timeline

• Start date: 2012-07-01
• Primary completion: 2019-03-01
• Completion: 2020-02-01
• First posted: 2012-09-11
• Last updated: 2019-08-15

Locations

2 sites across 1 country: United Kingdom