Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

NCT ID: NCT01180426

Last Updated: 2012-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.

Detailed Description

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Extension protocol to the OPAL Study (CHR-2797-038).

Study mimics normal clinical practice; few procedures and visits are therefore mandated by the protocol. Timing of bone marrow assessment is also left at the investigator's discretion.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tosedostat

Group Type EXPERIMENTAL

CHR-2797

Intervention Type DRUG

120mg once daily oral for 48 weeks

Interventions

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CHR-2797

120mg once daily oral for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed, informed consent
* Completion of Visit 11 in the OPAL Study (Month 6 Visit)
* Investigator's opinion that the subject would benefit from continued therapy with tosedostat.

Exclusion Criteria

* Any co-existing medical condition that in the Investigator's opinion will substantially increase the risk associated with the subject's participation in the study
* Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
* Administration of any (other) investigational agent within 14 days of entry into TOPAZ.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chroma Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCLA Division of Hematology/Oncology

Los Angeles, California, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

John Theurer Cancer Center

Hackensack, New Jersey, United States

Site Status

New York Presbyterian Hospitacl

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

MD Anderson

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CHR-2797-045

Identifier Type: -

Identifier Source: org_study_id

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