The phase II study in advanced non-small cell lung cancer (NSCLC) is a randomized trial that is expected to involve over 20 centers in the US and Europe and enroll approximately 120 patients. The primary objective of this study is to evaluate progression-free survival. The study will also examine overall survival, response rates and safety.
Patients in the phase II trial will be randomized to receive satraplatin plus Tarceva or Tarceva alone. A sequential dosing regimen will be used in the satraplatin arm. The treatment cycle for both arms is 28 days. Patients will be stratified according to smoking history and gender.
“Platinum-based combination therapies are often used to treat patients with advanced non-small cell lung cancer. However, elderly patients are frequently not treated with standard chemotherapy due to concerns about their ability to tolerate treatment,” said Dr Marcel Rozencweig, chief medical officer of GPC Biotech. “A combination regimen of satraplatin – an oral, well-tolerated platinum-based compound – in combination with another oral, well-tolerated drug such as Tarceva could, if effective, offer an important new treatment option for this under-served patient group.”
The company also announced that a phase III registrational trial exploring satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer has completed patient enrollment. GPC continues to open additional clinical studies to explore the potential of satraplatin in a variety of tumor types.