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

Phase 1

Completed

• Conditions: Recurrence of Solid Tumor; Glioblastoma Multiforme; Melanoma
• Interventions: Drug: MK-4827; Drug: Temozolomide

• Registration Number: NCT01294735
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-14
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part B, MK-4827 + temozolomide melanoma cohort	MK-4827	-
Part B, MK-4827 + temozolomide glioblastoma multiforme cohort	MK-4827	-
Part A, MK-4827 + temozolomide dose escalation cohort	MK-4827	-
Part A, MK-4827 + temozolomide dose escalation cohort	Temozolomide	-
Part B, MK-4827 + temozolomide melanoma cohort	Temozolomide	-
Part B, MK-4827 + temozolomide glioblastoma multiforme cohort	Temozolomide	-

Primary Outcome Measures

Name	Time	Method
Number of participants with DLTs	Cycle 1 (28 days)

Secondary Outcome Measures

Name	Time	Method
Number of participants with an objective response rate of partial or complete response	Baseline, Day 25 of each cycle, within 30 days of last dose, and at 2 month intervals until disease progression or new therapy initiated.
Number of participants with 6-month progression-free survival	6 months from baseline imaging
Progression-Free Survival (PFS)	First dose to progressive disease or death, whichever occurs first