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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
multiple dose, escalating
multiple dose, single schedule
Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Lafayette, Indiana, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel.
Time frame: One year
Characterize the safety profile of the study drug in combination with paclitaxel in terms of adverse events and clinical laboratory tests.
Time frame: One year
Assess the efficacy of the study drug in combination with paclitaxel in terms of tumor response, duration of response and progression-free survival.
Time frame: One year
Assess the potential plasma pharmacokinetic (PK) interactions between study drug, metabolites and paclitaxel in terms of plasma concentrations and noncompartmental PK parameters.
Time frame: One year
Assess possible PK/efficacy and PK/safety correlations.
Time frame: One year
Assess potential predictive biomarkers of clinical activity for the study drug in combination with paclitaxel.
Time frame: One year
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