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In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEK162 | Experimental | MEK162 will be administered orally once on Day 1 of Cycle 1 and continuously on a BID schedule, starting on Day 2 of Cycle 1 and on Day 1 of subsequent cycles. Each cycle will be 28 days in duration. Dose will be escalated and starting dose is 30 mg. Any doses that are missed should be skipped and should not be replaced or made up during the evening dosing or on a subsequent day, whichever applies. The prescribed BID doses should be taken 12 ± 2 hrs apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEK162 | Drug | MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets). |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose limiting toxicities | Incidence of frequency of Dose limiting toxicities during first 4 weeks will be measured according to the commen terminology criteria for adverse events (CTCAE). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events and serious adverse events, changes in laboratory values | Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment. | 4 months |
| Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigative Site | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Pfizer Investigative Site |
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| ID | Term |
|---|---|
| C581313 | binimetinib |
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Plasma concentration of MEK162 and active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite will be measured with serial plasma samples during treatment for first 2 months. |
| 2 months |
| Tumor responses according to RECIST 1.1 | Tumor responses will be measured according to RECIST 1.1 | 4 months |
| Levels of p-ERK in tumor and skin | Levels of p-ERK in tumor during treatment and skin for first 2 weeks will be measured. | 4 months |
| Yufu |
| Oita Prefecture |
| 879-5593 |
| Japan |