A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
NCT01649336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2020-09-14
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
- DRUG
-
MEK162, MEK inhibitor; oral
multiple dose, escalating
- DRUG
-
Paclitaxel, mitotic inhibitor; intravenous
multiple dose, single schedule
Sponsors & Collaborators
-
Array Biopharma, now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2016-03-31
- Completion
- 2016-03-31
Countries
- United States
Study Locations
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