Clinical trial
Olaparib with or without cediranib in treating patients with metastatic hormone-resistant prostate cancer
This randomized phase II trial studies how well olaparib with or without cediranib works in treating patients with hormone-resistant prostate cancer that has spread to other places in the body. Olaparib and cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of Cediranib in Combination With Olaparib Versus Olaparib Alone in Men With Metastatic Castration Resistant Prostate Cancer
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm I (olaparib)
Patients receive olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Olaparib
Given PO
Other Names:
|
| Experimental: Arm II (olaparib, cediranib)
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Drug: Cediranib
Given PO
Other Name: AZD2171
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Olaparib
Given PO
Other Names:
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| Category | Value |
|---|---|
| Date last updated at source | 2016-09-08 |
| Study type(s) | Randomised clinical trial |
| Expected enrolment | 84 |
| Study start date | 2016-12-01 |
| Estimated primary completion date | 2018-11-01 |