Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome Myeloproliferative Disorders

Keywords

LeukemiaAdvanced hematologic malignanciesEpizymePhase 1Mixed Lineage Leukemia (MLL)

Outcome Measures

Primary Outcomes (1)

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.
The MTD is defined as the dose level below in which \>1 patient out of 3 or \>2 patients out of 6 experience dose-limiting adverse events (as defined by the protocol).
up to 12 months

Secondary Outcomes (5)

Pharmacokinetic profile of EPZ-5676
up to 24 months
The incidence of adverse events in patients treated with EPZ-5676
up to 24 months

Study Arms (1)

EPZ-5676 Extension cohort

EXPERIMENTAL

Drug: EPZ-5676

Interventions

EPZ-5676Drug

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.

EPZ-5676 Extension cohort

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

Celgene
Industrycollaborator
Epizyme, Inc.
Industrylead

Study Sites (8)

Mayo Clinic Scottsdale-Phoenix

Scottsdale, Arizona, 85259, United States

Northwestern University

Chicago, Illinois, 60611, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Duke University Health System

Durham, North Carolina, 27710, United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

UT MD Anderson Cancer

Houston, Texas, 77030, United States

Universitätsklinikum Ulm

Ulm, 89081, Germany

Related Publications (1)

Stein EM, Garcia-Manero G, Rizzieri DA, Tibes R, Berdeja JG, Savona MR, Jongen-Lavrenic M, Altman JK, Thomson B, Blakemore SJ, Daigle SR, Waters NJ, Suttle AB, Clawson A, Pollock R, Krivtsov A, Armstrong SA, DiMartino J, Hedrick E, Lowenberg B, Tallman MS. The DOT1L inhibitor pinometostat reduces H3K79 methylation and has modest clinical activity in adult acute leukemia. Blood. 2018 Jun 14;131(24):2661-2669. doi: 10.1182/blood-2017-12-818948. Epub 2018 May 3.
PMID: 29724899DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesMyeloproliferative DisordersLeukemia

Interventions

EPZ-5676

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic Diseases

Study Officials

Martin S. Tallman, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR
Jesus Berdeja, MD
SCRI Development Innovations, LLC
PRINCIPAL INVESTIGATOR
David A Rizzieri, MD
Duke University
PRINCIPAL INVESTIGATOR
Guillermo Garcia-Manero, MD
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

51 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 6, 2012

First Posted

September 12, 2012

Study Start

September 2012

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

EPZ-5676 Extension cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

EPZ-5676 Extension cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations