- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01180426
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
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
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California
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Los Angeles, California, United States, 90095
- UCLA Division of Hematology/Oncology
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Michigan
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Ann Arbor, Michigan, United States, 48109-2800
- University of Michigan
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New Jersey
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Hackensack, New Jersey, United States, 07601
- John Theurer Cancer Center
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New York
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New York, New York, United States, 10021
- New York Presbyterian Hospitacl
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Texas
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Houston, Texas, United States, 77030-4009
- MD Anderson
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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
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120mg once daily oral for 48 weeks
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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:
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Protocol mandated visits every 12 weeks
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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:
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Protocol-mandated visits every 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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Chroma TherapeuticsCompleted
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