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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEK162 + paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEK162, MEK inhibitor; oral | Drug | multiple dose, escalating |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety profile of the study drug in combination with paclitaxel in terms of adverse events and clinical laboratory tests. | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Scottsdale | Arizona | United States | |||
| Pfizer Investigational Site |
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| Paclitaxel, mitotic inhibitor; intravenous |
| Drug |
multiple dose, single schedule |
|
| One year |
| Assess the potential plasma pharmacokinetic (PK) interactions between study drug, metabolites and paclitaxel in terms of plasma concentrations and noncompartmental PK parameters. | One year |
| Assess possible PK/efficacy and PK/safety correlations. | One year |
| Assess potential predictive biomarkers of clinical activity for the study drug in combination with paclitaxel. | One year |
| Lafayette |
| Indiana |
| United States |
| Pfizer Investigational Site | New York | New York | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | United States |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C581313 | binimetinib |
| D017239 | Paclitaxel |
| D050256 | Antimitotic Agents |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D050258 | Mitosis Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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