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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders

In brief

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).

Key facts

Study ID: NCT01684150
Run by: Epizyme, Inc.
People needed: 51
Starts: 2012-09-01
Expected to finish: 2016-02-01
Last updated by the study team: 2024-03-26

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female patients aged ≥ 18 years.
Patients with relapsed /refractory AML, ALL, or MLL with rearrangement of the MLL gene, including 11q23 or PTD, are eligible for the expanded cohort:
At least one prior therapy;
Refractory disease on most recent therapy, or disease recurrence following remission on most recent therapy;
Received and failed all known effective therapies for their disease;
Not a candidate for allogeneic stem cell transplantation
> 10% blasts or biopsy-documented leukemia cutis or myeloid sarcoma.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Patients must have the following clinical laboratory values:
Serum creatinine ≤2 mg/dL or creatinine clearance > 60 mL/minute;
Total bilirubin ≤2.0 times the ULN for the institution, unless considered due to Gilbert's syndrome;
ALT or AST ≤ twice the upper limit of normal (ULN), unless considered due to organ leukemic involvement;
Absolute neutrophil count ≥1,000/µL (unless due to documented leukemic involvement of the bone marrow at the time of study entry)
Platelets ≥100,000/µL (unless due to documented leukemic involvement of the bone marrow at the time of study entry).
PT or aPTT < 1.5 times the ULN
Able and willing to give written informed consent.
Life expectancy of at least 3 months

You may not qualify if…

Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
Active heart disease
Receiving any other standard treatment for their hematologic malignancy.
Receiving strong CYP3A4 inhibitors/ inducers.
Known history of cerebrovascular accident in the past 6 months.
Known bleeding diathesis.
Known, active (symptomatic) involvement of the central nervous system by leukemia.
On immunosuppressive therapy.
Known active infection.
Pregnant or nursing females.

Where it is running

Mayo Clinic Scottsdale-Phoenix — Scottsdale, Arizona, United States
Northwestern University — Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Duke University Health System — Durham, North Carolina, United States
Sarah Cannon Research Institute — Nashville, Tennessee, United States
UT MD Anderson Cancer — Houston, Texas, United States
Universitätsklinikum Ulm — Ulm, Germany
Erasmus University Medical Center — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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