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Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chroma Therapeutics
ClinicalTrials.gov Identifier:
NCT01180426
First received: August 5, 2010
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
 Drug: CHR-2797
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chroma Therapeutics:

Primary Outcome Measures:
  • Safety and Tolerability of extended treatment with tosedostat [ Time Frame: Protocol mandated visits every 12 weeks ] [ Designated as safety issue: Yes ]

    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


Secondary Outcome Measures:
  • Efficacy of extended treatment with tosedostat [ Time Frame: Protocol-mandated visits every 12 weeks ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tosedostat Drug: CHR-2797
120mg once daily oral for 48 weeks

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180426

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

No publications provided

Responsible Party: Chroma Therapeutics
ClinicalTrials.gov Identifier: NCT01180426     History of Changes
Other Study ID Numbers: CHR-2797-045
Study First Received: August 5, 2010
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Chroma Therapeutics:
Relapse Refractory Acute Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013