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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

NCT01684150 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-03-26

No results posted yet for this study

Summary

The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias bearing rearrangements of the MLL gene.

Currently this study is in the MLL-r restricted/expansion phase and is only enrolling patients with rearrangements involving the MLL gene, including 11q23 or partial tandem duplications (PTD).

Conditions

Interventions

DRUG

EPZ-5676

MLL-r and MLL-PTD 28-day continuous IV infusion of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity develops.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Epizyme, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin S. Tallman, MD · Memorial Sloan Kettering Cancer Center

  • Jesus Berdeja, MD · SCRI Development Innovations, LLC

  • David A Rizzieri, MD · Duke University

  • Guillermo Garcia-Manero, MD · M.D. Anderson Cancer Center

  • Jessica Altman, MD · Northwestern University

  • Raoul Tibes, MD · Mayo Clinic Scottsdale-Phoenix

  • Mojca Jongen-Lavrencic, MD · Erasmus Medical Center

  • Hartmut Döhner, MD · Universitätsklinikum Ulm

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-11-30
Completion
2016-02-29

Countries

  • United States
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684150 on ClinicalTrials.gov