TOPARP: A Phase II Trial of Olaparib in Patients With Advanced Castration Resistant Prostate Cancer
TOPARP: A Phase II Trial of Olaparib in Patients With Advanced Castration Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT01682772
Sponsor: Institute of Cancer Research, United Kingdom
Information provided by: Institute of Cancer Research, United Kingdom (Responsible Party)
Last Update Posted: 2019-08-15
Brief 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
Official Title:
A Phase II Trial of Olaparib in Patients With Advanced Castration Resistant Prostate Cancer (TOPARP)
| Category | Value |
|---|---|
| Study Start (Actual) | 2012-07 |
| Primary Completion (Actual) | 2019-03 |
| Study Completion (Estimated) | 2020-02 |
| Enrollment (Actual) | 148 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
ICR-CTSU/2011/10030
2011-000601-49 (EudraCT Number) CRUK/C12540/A12354 (Other Grant/Funding Number) (OTHER_GRANT: Cancer Research UK) ISRCTN15124653 (Registry Identifier) (REGISTRY: Randomised Controlled Trials) ISS22810018 (Other Grant/Funding Number) (OTHER_GRANT: Astra Zeneca) |