NCT01649336

A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	MEK162, MEK inhibitor; oral	multiple dose, escalating
DRUG	Paclitaxel, mitotic inhibitor; intravenous	multiple dose, single schedule

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2012-07-25
• Last updated: 2020-09-14

Locations

4 sites across 1 country: United States