Conditions: Neoplasms Malignant
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 27
Healthy volunteers: no

Brief summary:
This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.

Detailed description:

Arms:
arm 1: Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle arm 2: Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle arm 3: Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle arm 4: Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle arm 5: Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle arm 6: Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle arm 7: Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle arm 8: Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle arm 9: Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle

Interventions: intervention 1: MK-1496 intervention 2: MK-1496
Intervention descriptions: intervention 1: MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle intervention 2: MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle

Protocol document: