Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

February 14, 2012 updated by: Chroma Therapeutics

The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Division of Hematology/Oncology
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2800
        • University of Michigan
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospitacl
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • MD Anderson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tosedostat
Drug: CHR-2797
120mg once daily oral for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of extended treatment with tosedostat
Time Frame: Protocol mandated visits every 12 weeks

Primary outcome will be assessed using the following procedures/data:

  • Physical exams
  • Vital signs
  • Electrocardiography
  • Laboratory parameters (hematology, chemistry, urinalysis)
  • Adverse events
  • Serious adverse events
Protocol mandated visits every 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of extended treatment with tosedostat
Time Frame: Protocol-mandated visits every 12 weeks

The secondary outcome will be assessed using the following parameters:

  • Overall survival
  • Relapse-free survival
  • Event-free survival
  • Clinical responses (Complete Remission, Complete Remission with Incomplete Platelet Recovery, Morphological Leukemia-Free State, Partial Remission, Stable Disease, Progressive Disease) including best response and time to response
  • Duration of clinical responses.
Protocol-mandated visits every 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chroma Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHR-2797-045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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