drugset / Trial / NCT01294735

Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1)

NCT01294735

Phase 1 Completed 19 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a non-randomized two-part study of MK-4827 given with temozolomide in participants with advanced cancer. In Part A of the study, the dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of MK-4827 when combined with temozolomide will be found by increasing the MK-4827 dose level in successive cohorts. In Part B of the study, participants with advanced glioblastoma multiforme and advanced melanoma will be enrolled to further evaluate the tolerability and efficacy of the MK-4827 + temozolomide combination.

Timeline

Start
2011-02
Primary completion
2012-04
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Niraparib Small molecule
Subject Temozolomide Small molecule

Indications