Conditions: Locally Advanced Tumors Metastatic Solid Tumors Cancer Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 104
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to investigate the Dose Limiting Toxicities (DLTs), pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2206 administered orally to participants with advanced solid tumors. The preliminary efficacy of MK-2206 will also be investigated.

Detailed description:

Arms:
arm 1: Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles. arm 2: Participants receive 60 mg oral MK-2206 QOD in repeating 4-week treatment cycles. arm 3: Participants receive 75 mg oral MK-2206 QOD in repeating 4-week treatment cycles. arm 4: Participants receive 90 mg oral MK-2206 QOD in repeating 4-week treatment cycles. arm 5: Participants receive 90 mg oral MK-2206 every week (QW) in repeating 4-week treatment cycles. arm 6: Participants receive 135 mg oral MK-2206 QW in repeating 4-week treatment cycles. arm 7: Participants receive 200 mg oral MK-2206 QW in repeating 4-week treatment cycles. arm 8: Participants receive 300 mg oral MK-2206 QW in repeating 4-week treatment cycles. arm 9: Participants receive 250 mg oral MK-2206 QW in repeating 4-week treatment cycles. arm 10: Participants receive 150 mg oral MK-2206 QW in repeating 4-week treatment cycles.

Interventions: intervention 1: MK-2206
Intervention descriptions: intervention 1: MK-2206 administered as an oral formulation in rising dose levels on a QOD schedule (30 mg, 60 mg, 75 mg, and 90 mg) or QW schedule (90 mg, 135 mg, 200 mg, 250 mg, and 300 mg) in repeating 4 week cycles, depending upon allocation.

Protocol document: