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

COMPLETEDPHASE1

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

A Phase I Study of MK-4827 in Combination With Temozolomide in Patients With Advanced Cancer

NCT01294735•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Part A
•Participants with histologically-confirmed advanced solid tumors who have failed to respond to standard therapy, or progressed on standard therapy, or for whom standard therapy does not exist.
•Part B
•Participants must have a histologically-confirmed recurrent glioblastoma multiforme (GBM) with radiographic evidence of progression/recurrence of disease, with up to two prior treatment regimens (not including temozolomide or bevacizumab) for their recurrent disease.
•OR
•Participants must have histologically-confirmed recurrent or metastatic melanoma for which the participant has received up to two prior therapies.
•Participants must not have received prior treatment with cytotoxic chemotherapy including temozolomide, dacarbazine, or PARP inhibitors.
•Part A and Part B
•Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•Participants must have adequate organ function.
+3 more criteria

Exclusion Criteria

•Participant has had chemotherapy, radiotherapy, or biological therapy within four weeks prior to study Day 1 (six weeks for nitrosoureas and mitomycin C) or who has not recovered from adverse events due to agents administered more than four weeks earlier.
•Participants with known symptomatic or progressive Central Nervous System (CNS) metastases and/or carcinomatous meningitis.
•Participant has prior exposure to PARP inhibitors. Prior exposure to temozolomide is allowed only for participants with GBM, provided it was received in the adjuvant setting with GBM progression after completion of adjuvant temozolomide treatment and a treatment-free interval of ≥ 3 months.
•Participant has significant or uncontrolled cardiovascular disease, including New York Heart Association (NYHA) Class III-IV heart failure, unstable angina, or a myocardial infarction within the last six months.
•Participant is breastfeeding.
•Participant is known to be Human Immunodeficiency Virus (HIV)-positive.
•Participant has active Hepatitis B or C.
•Participant has symptomatic ascites or pleural effusion.
•Participant has a requirement for concurrent treatment with immunosuppressive agents.
•Participant must not have prior radiation therapy to more than 30% of hte bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy.
+1 more criteria

Key Dates

Start Date

February 1, 2011

Primary Completion Date

April 1, 2012

Completion Date

May 1, 2012

Last Updated

August 15, 2012

Enrollment

ACTUAL participants

Conditions

Recurrence of Solid TumorGlioblastoma MultiformeMelanoma

Interventions

MK-4827

DRUG

Temozolomide

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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