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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_509 |
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This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QOD Schedule | Experimental | QOD Schedule, MK2206 every other day |
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| QW Schedule | Experimental | QW Schedule, MK2206 once weekly |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK2206 every other day | Drug | Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 45 mg and 60 mg, once daily every other day in repeating 4 week cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs) | Day 1 - Day 28 (Cycle 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax | Day 1 - Day 28 (Cycle 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26104654 | Background | Doi T, Tamura K, Tanabe Y, Yonemori K, Yoshino T, Fuse N, Kodaira M, Bando H, Noguchi K, Shimamoto T, Ohtsu A. Phase 1 pharmacokinetic study of the oral pan-AKT inhibitor MK-2206 in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Aug;76(2):409-16. doi: 10.1007/s00280-015-2810-z. Epub 2015 Jun 24. |
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| ID | Term |
|---|---|
| C548887 | MK 2206 |
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| MK2206 once weekly | Drug | Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 135 mg and 200 mg, once weekly in repeating 4 week cycles. |
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