CLINICAL TRIAL SUMMARY

MDACC Study No:2011-0547 (clinicaltrials.gov NCT No: NCT01451437)
Title:A Phase 1 Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 Administered Alone and in Combination with Chemotherapy in Subjects with Refractory, or Recurrent Acute Myelogenous Leukemia
Principal Investigator:Farhad Ravandi-Kashani
Treatment Agent:MK-8242
Study Status:Closed
Study Description:The purpose of this study is to look for a safe dose of the study drug, MK-8242
(also known as SCH900242), that is well tolerated when given alone or with
chemotherapy to patients with AML.

This study is divided into two treatment arms, and each arm has two parts as
explained below:

Treatment Arm A: Patients in this arm of the study will receive treatment only
with MK-8242.
Part 1 of treatment Arm A will try to find the highest dose of MK-8242 that can
be given safely, is well tolerated, and is absorbed, distributed, broken down
and eliminated by the body in an acceptable way.
Part 2 of treatment Arm A will confirm the safe and tolerable dose from Part
1. Part 2 will also assess if MK-8242 is effective by looking at how the
disease state of patients in this treatment group respond to treatment.

Treatment Arm B: Patients in this arm of the study will receive treatment with
MK-8242 and cytarabine.
Part 1 of treatment Arm B will try to find the highest dose of MK-8242 that can
be given with cytarabine safely, is well tolerated, and is absorbed,
distributed, broken down and eliminated by the body in an acceptable way.
Part 2 of treatment Arm B will confirm the safe and tolerable dose of MK-8242
that can be given with cytarabine from Part 1. Part 2 will also assess if
MK-8242, when combined with cytarabine, is effective by looking at how the
disease state of the patients in this treatment group respond to treatment.

Part 2 will enroll only AML patients with a non-mutated form of a gene called
TP53.

There may be reasons why you are not allowed to take part in this study. The
study doctor or staff will discuss these with you.

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Disease Group:Leukemia
Phase of Study:Phase I
Treatment Agents:MK-8242
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Farhad Ravandi-Kashani
Dept:Leukemia
For Clinical Trial Enrollment:713-792-5630
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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