Poniard Presents Positive Results From Phase II Prostate Cancer Trial
Posted on: Monday, 2 June 2008, 09:22 CDT
Poniard Pharmaceuticals has presented preliminary safety and efficacy data from its ongoing Phase II clinical trial of picoplatin in combination with docetaxel and prednisone, the standard of care for the first-line treatment of metastatic hormone-refractory prostate cancer.
In the ongoing Phase II trial, the efficacy and safety of intravenous picoplatin (120mg/m squared) administered every 21 days in combination with full-dose docetaxel (75mg/m squared) with daily prednisone (5mg) as a first-line treatment is being evaluated in 30 patients with metastatic hormone-refractory prostate cancer (HRPC).
Prostate specific antigen (PSA) response (defined as a PSA reduction of at least 50% from baseline) is the primary endpoint; secondary endpoints include safety, response rate, time to progression and overall survival. The trial completed enrollment in December 2007.
Results to date have shown a PSA response in 18 of 26 (69%) evaluable patients. Furthermore, PSA levels have normalized in six patients (21%). The combination of picoplatin and docetaxel can be safely administered with manageable and reversible neutropenia as the main hematologic toxicity. Results demonstrated that picoplatin can be safely administered with full doses of docetaxel. These data confirm earlier results observed in the Phase I trial. In contrast to picoplatin monotherapy, thrombocytopenia was less severe and less frequent. Neurotoxicity has not been observed in this study.
Robert De Jager, chief medical officer of Poniard, said: "The promising results of this Phase II trial in HRPC support further development of picoplatin in the treatment of prostate cancer. A prospective randomized trial is under consideration."
Source: Datamonitor
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