Conditions: Tumor, Solid
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 25
Healthy volunteers: no

Brief summary:
This study of the safety, tolerability, and efficacy of MK-8353 (formerly SCH 900353) given as single agent oral therapy for participants with advanced solid tumors will be done into two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2 dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to see if MK-8353 is effective as single agent therapy.

Detailed description:

Arms:
arm 1: 100 mg capsules administered orally twice daily for 28 days for each cycle arm 2: 200 mg capsules administered orally twice daily for 28 days for each cycle arm 3: 300 mg capsules administered orally twice daily for 28 days for each cycle arm 4: 350 mg capsules administered orally twice daily for 28 days for each cycle arm 5: 400 mg capsules administered orally twice daily for 28 days for each cycle arm 6: 800 mg capsules administered orally twice daily for 28 days for each cycle

Interventions: intervention 1: MK-8353
Intervention descriptions: intervention 1: Administered orally twice daily for 28 days for each cycle

Protocol document: