GPC Biotech Announces Initiation of NCI-Sponsored Phase 2 Trial of Satraplatin
News Jun 25, 2008
GPC Biotech AG has announced the initiation of a Phase 2 study evaluating satraplatin in combination with the steroid, prednisone, in patients with metastatic hormone-refractory prostate cancer (HRPC) who previously have been treated with docetaxel (Taxotere®).
The study is being sponsored by the U.S. National Cancer Institute (NCI), and the principal investigator is William L. Dahut, MD, Chief, Genitourinary Research Section, Medical Oncology Branch, Center for Cancer Research, NCI.
The trial is a single-arm study with a planned enrollment of 66 patients with metastatic HRPC who have been previously treated with docetaxel therapy and with no more than one other previous cytotoxic chemotherapy regimen.
The primary objective of the trial is to determine if the presence of certain variants of the gene, ERCC1, affects progression-free survival in this patient population. ERCC1 is involved in DNA damage repair. Satraplatin, like other platinum agents, has been shown to work via targeting the DNA in tumor cells.
“The results of this trial may provide important information in determining which hormone-refractory prostate cancer patients are more likely to benefit from treatment with satraplatin,” said Martine George, MD, Senior Vice President, Drug Development and Chief Medical Officer at GPC Biotech. “We are pleased to be working with the NCI to conduct this potentially ground-breaking study.”