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Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01180426
Recruitment Status : Unknown
Verified February 2012 by Chroma Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2010
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Chroma Therapeutics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: CHR-2797 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2010
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tosedostat Drug: CHR-2797
120mg once daily oral for 48 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180426


Locations
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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
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Responsible Party: Chroma Therapeutics
ClinicalTrials.gov Identifier: NCT01180426    
Other Study ID Numbers: CHR-2797-045
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012
Keywords provided by Chroma Therapeutics:
Relapse Refractory Acute Myeloid Leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
 Neoplasms
Tosedostat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action