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A Randomized Phase II Study of OGX-427 (a Second-Generation Antisense Oligonucleotide to Heat Shock Protein-27) in Patients With Castration Resistant Prostate Cancer Who Have Not Previously Received Chemotherapy for Metastatic Disease
This study is being offered to patients who have castrate-resistant (also known as hormone-refractory) prostate cancer. The cancer has metastasized or spread outside the prostate area to other parts of the body or has recurred in the pelvic area after treatment. The purpose of this clinical research study is to determine whether OGX-427 is able to slow the progression of prostate cancer and symptoms of disease when given with prednisone better than when prednisone is given alone in patients with prostate cancer whose disease has spread outside the prostate area. Research Hypothesis: That adding OGX-427 to prednisone treatment will produce a progression free rate of 20%.
Details
| Lead sponsor | British Columbia Cancer Agency |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 74 |
| Start date | 2010-09 |
| Completion | 2014-06 |
Conditions
- Castration Resistant Prostate Cancer
Interventions
- OGX-427
- Prednisone
Primary outcomes
- Disease Progression — 12 weeks
The primary efficacy endpoint is defined as the proportion of patients without disease progression at the 12-week evaluation after treatment with prednisone given with or without OGX-427.
Countries
United States, Canada