A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving Translocation of the MLL Gene at 11q23 or Advanced Hematologic Malignancies
A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia
(ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or
flourescent in-situ hybridization evaluation at the time of diagnosis. A protein called
DOT1L plays an important role in the malignant process in these leukemias. EPZ-5676 is a
molecule that blocks the activity of DOT1L, and is therefore being evaluated in the
treatment of patients with MLL-rearranged leukemias.
This is a first-in-human study of EPZ-5676. The primary purpose of this study is to
determine what dose of EPZ-5676, when administered as a 21-day continuous intravenous
infusion, can be given safely to patients with hematologic malignancies. The study will have
two phases. The first phase will assess escalating doses of EPZ-5676 in order to determine
the maximally tolerated dose (MTD) of EPZ-5676. Once the MTD is established, a second phase
of the study will further evaluate the safety of EPZ-5676 and assess the anti-leukemia
activity of EPZ-5676 in MLL-rearranged leukemia.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The maximum tolerated dose (MTD) of EPZ-5676 as determined by incidence of protocol-specified dose-limiting adverse events
The MTD is defined as one dose level below the level in which >1 dose-limiting adverse events (as defined by the protocol) are observed.
up to 12 months
Yes
Martin S. Tallman, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
EPZ-5676-12-001
NCT01684150
September 2012
November 2014
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Duke University Health System | Durham, North Carolina 27705 |
UT MD Anderson Cancer | Houston, Texas 77030 |