The outcome of the trail has been notified to the investigators involved in the study and to the regulatory agencies. It has not noticed any new or unexpected serious adverse events in the patupilone arm during the trial. Novartis does not plan to proceed with regulatory filings based on these data.
Patupilone belongs to a class of microtubule stabilizers called epothilones and is being evaluated in ongoing trials in multiple tumor types, including metastatic colorectal cancer, brain metastases in non-small cell lung cancer (NSCLC) and hormone-refractory prostate cancer (HRPC).
The Phase III study, conducted in approximately 168 sites in 22 countries, was an open label, active controlled, parallel group, multicenter trial of 829 patients with epithelial ovarian, primary fallopian or primary peritoneal cancer, who were randomized to receive patupilone or Doxil/Caelyx.
Before enrollment in the trial, patients had received up to a maximum of three prior chemotherapeutic regimens, of which the first was a taxane/platinum therapy. Patients were randomly assigned to intravenous patupilone (10 mg/m2) once every three weeks or Doxil/Caelyx (50 mg/m2) once every four weeks and were evaluated for disease status by Ca-125 and CT scans every eight weeks until disease progression. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, safety and overall response rate.