Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
NCT ID: NCT00700206
Last Updated: 2011-10-12
Study Results
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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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2008-05-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Dose Schedule 1: Two weeks treatment with Telintra 3000 mg per day in two divided doses followed by one week with no treatment per three week cycle.
Ezatiostat Hydrochloride
Dose Schedule 1-3000 mg orally per day in two divided doses for two weeks followed by 1 week with no treatment per three week cycle.
Dose Schedule 2-2000 mg orally per day in two divided doses for three weeks followed by 1 week with no treatment per four week cycle.
2
Dose Schedule 2: Three weeks treatment with Telintra 2000 mg per day in two divided doses followed by one week with no treatment per four week cycle.
Ezatiostat Hydrochloride
Dose Schedule 1-3000 mg orally per day in two divided doses for two weeks followed by 1 week with no treatment per three week cycle.
Dose Schedule 2-2000 mg orally per day in two divided doses for three weeks followed by 1 week with no treatment per four week cycle.
Interventions
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Ezatiostat Hydrochloride
Dose Schedule 1-3000 mg orally per day in two divided doses for two weeks followed by 1 week with no treatment per three week cycle.
Dose Schedule 2-2000 mg orally per day in two divided doses for three weeks followed by 1 week with no treatment per four week cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Low or intermediate-1 MDS
* ECOG performance status 0 or 1
* Documented significant anemia with or without neutropenia and/or thrombocytopenia
* Adequate kidney and liver function
* Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry
Exclusion Criteria
* History of MDS IPSS score greater than 1.0
* Pregnant or lactating women
* Any severe concurrent disease, infection, or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
* Oral steroids e.g. prednisone \>10 mg per day
* History of active hepatitis B or C
* Known history of HIV
18 Years
ALL
No
Sponsors
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Telik
INDUSTRY
Responsible Party
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Principal Investigators
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Gail Brown, MD
Role: STUDY_DIRECTOR
Telik
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States
St. Jude Heritage Healthcare
Fullerton, California, United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States
UCLA Medical Center
Los Angeles, California, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, United States
North Valley Hematology/Oncology Medical Group
Northridge, California, United States
Bay Area Cancer Research Group
Pleasant Hill, California, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States
Sansum Clinic
Santa Barbara, California, United States
Santa Barbara Hematology Medical Group, Inc.
Santa Barbara, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
University of Colorado at Denver Health Sciences Center
Aurora, Colorado, United States
The Center for Hematology Oncology
Boca Raton, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
Suburban Hematology-Oncology Associates, P.C.
Lawrenceville, Georgia, United States
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States
Loyola University Chicago
Maywood, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Central Hematology Oncology Medical Group, Inc.
Terre Haute, Indiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Case Western Reserve University/University Hospitals of Cleveland
Cleveland, Ohio, United States
Hematology & Medical Oncology
Cleveland, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Kaiser Permanente
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Countries
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Other Identifiers
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TLK199.2101
Identifier Type: -
Identifier Source: org_study_id