NCT02141828|CompletedPhase 1
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Sponsor study identifier
interventional
18
2 countries
9
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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 fluorescent 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 11, 2014
Actual (reported)May 20, 2014
Actual (reported)May 2016
Actual (reported)June 2016
Actual (reported)Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of EPZ-5676.
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of EPZ-5676 as determined by incidence of protocol-specified dose-limiting adverse events.
12 months
To assess the safety and tolerability of EPZ-5676 administered as a continuous intravenous (CIV) infusion
Safety and tolerability will be assessed by the incidence of adverse events in patients treated with EPZ-5676 and the evaluation of adverse events, vital signs, physical examination, 12-lead ECG, and laboratory assessments.
22 months
Determine the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EPZ-5676
EPZ-5676 Dose escalation and expansion cohorts
28-day continuous IV infusion of each 28-day cycle, given until disease progression or unacceptable toxicity develops.
Childrens Hospital Los Angeles
Los Angeles, California, 90027, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Emory Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
Neal Shukla, MD
Memorial Sloan Kettering Cancer Center
Lia Gore, MD
Children's Hospital Colorado
Pat Brown, MD
Johns Hopkins University
Lewis Silverman, MD
Dana Farber
18 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2014
First Posted
May 20, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
18 months
Evaluate early evidence of anti-tumor activity
18 months
To determine cerebrospinal fluid (CSF) concentrations EPZ-5676 in pediatric patients receiving EPZ-5676 by CIV infusion
18 months
Analysis of tumor cells for somatic mutations as potential predictors of response
18 months
Contact the study team to confirm eligibility.
New York, New York, 10065, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
The Hospital for Sick Kids
Toronto, Ontario, Canada
Maureen O'Brien, MD
Children's Hospital Medical Center, Cincinnati
Jim A Whitlock, MD
Hospital of Sick Kids
Cynthia Wetmore, MD PhD
Emory Children's Healthcare of Atlanta
Mignon Loh, MD
University of California, San Francisco
Paul Gaynon, MD
Children's Hospital Los Angeles
Todd Cooper, MD
Seattle Children's Hospital
Primary Completion
May 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
June 18, 2023
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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