Phase 2/3 Study of Masitinib in Combination With Gemcitabine Versus Gemcitabine Alone in Advanced/Metastatic Epithelial Ovarian Cancer Patients in Second Line Being Refractory to First Line Platinum Treatment or in Third Line
PhasePhase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion Criteria
- Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer (including primary peritoneal and primary fallopian tube cancer), which is either: - First line platinum-refractory ovarian cancer (progression during first-line platinum-based chemotherapy) - First line platinum-resistant ovarian cancer (relapsing within 6 months after the end of first-line chemotherapy); - Candidate to third line of treatment (refractory, resistant, or sensitive to 2nd line platinum-based therapy or patients who progressed after other type of chemotherapy in 2nd line).
- Patient with adequate organ function per laboratory tests evaluations Main
- Patient intolerant to gemcitabine
- Patient who has not recovered from any significant treatment toxicities prior to baseline (≥Grade 2)
- Pregnant or nursing female patient
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.