drugset / Trial / NCT01463696

Study of Safety and Pharmacokinetics of MK-8242 in Participants With Advanced Solid Tumors (P07650)

NCT01463696 ↗

Phase 1 Terminated 48 enrolled Merck Sharp & Dohme LLC
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is being done to evaluate the safety and pharmacokinetic profile of MK-8242 and its active metabolite (M16) in participants with advanced solid tumors. In Part 1 of the study, the study drug dose will be escalated to determine the maximum tolerated dose (MTD). In Part 2 of the study, the MTD will be confirmed and the recommended Phase 2 dose (RPTD) established; the effect of MK-8242 on liposarcoma and other tumor types will also be evaluated.

Timeline

Start
2011-12-21
Primary completion
2014-09-15
Completion
2015-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8242 Unknown 60 mg Oral
Subject MK-8242 Unknown 120 mg Oral
Subject MK-8242 Unknown 170 mg Oral
Subject MK-8242 Unknown 250 mg Oral
Subject MK-8242 Unknown 300 mg Oral
Subject MK-8242 Unknown 350 mg Oral
Subject MK-8242 Unknown 400 mg Oral
Subject MK-8242 Unknown 500 mg Oral

Indications