MDACC Study No:2012-0374 ( NCT No: NCT01684150)
Title:A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic Malignancies
Principal Investigator:Guillermo Garcia-Manero
Treatment Agent:EPZ-5676
Study Status:Closed
Study Description:There are 2 parts to this study: Part A (dose escalation) and Part B (dose

The goal of Part A of this clinical research study is to find the highest
tolerable dose of EPZ-5676 that can be given to patients with leukemia or
another cancer of the blood that has relapsed or refractory. This part of the
study has been completed.

The goal of Part B of this clinical research study is to learn if the dose of
EPZ-5676 found in Part A can help to control the disease.

EPZ-5676 is designed to turn off genes that are believed to cause the leukemia
cells to form, which may kill the leukemia cells. This is the first study in
which it will be given to humans.
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Disease Group:Hematologic Disorder; Leukemia
Phase of Study:Phase I
Treatment Agents:EPZ-5676
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Epizyme, Inc.
Return Visit:
Home Care:

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Physician Name:Guillermo Garcia-Manero
For Clinical Trial Enrollment:713-745-3428
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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