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A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
This is a Phase 1 study during which patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer will receive investigational study drug MEK162 and paclitaxel. Patients will receive increasing doses of study drug in combination with paclitaxel in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 36 patients from the US will be enrolled in this study.
Details
| Lead sponsor | Array Biopharma, now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2012-07 |
| Completion | 2016-03 |
Conditions
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Peritoneal Cancer
Interventions
- MEK162, MEK inhibitor; oral
- Paclitaxel, mitotic inhibitor; intravenous
Primary outcomes
- Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel. — One year
Countries
United States