Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
Study NCT ID:
NCT00700206
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2008-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C096329', 'term': 'gamma-Glu-S-BzCys-PhGly diethyl ester'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-10', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematologic Improvement-Erythroid (HI-E) rate', 'timeFrame': '24 Weeks'}], 'secondaryOutcomes': [{'measure': 'Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments.', 'timeFrame': '24 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hematology', 'MDS', 'Myelodysplastic Syndrome', 'Low Risk MDS', 'Intermediate-1 risk MDS', 'Int-1 risk MDS', 'Telintra', 'ezatiostat hydrochloride', 'ezatiostat', 'TLK199', 'Glutathione', 'Glutathione analog', 'Glutathione Transferase', 'Glutathione Transferase inhibitor', 'Glutathione Transferase P1-1 inhibitor', 'GSTp1-1 inhibitor', 'Apoptosis', 'Differentiation', 'Enzyme inhibitor'], 'conditions': ['Myelodysplastic Syndrome (MDS)']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of Telintra in patients with Low or Intermediate-1 risk MDS. Patients at least 18 years of age presenting with histologically confirmed Low to Intermediate-1 risk MDS with documented significant cytopenia for at least two months by the IWG criteria are eligible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary or de novo MDS\n* Low or intermediate-1 MDS\n* ECOG performance status 0 or 1\n* Documented significant anemia with or without neutropenia and/or thrombocytopenia\n* Adequate kidney and liver function\n* Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry\n\nExclusion Criteria:\n\n* Prior allogenic bone marrow transplant for MDS\n* History of MDS IPSS score greater than 1.0\n* Pregnant or lactating women\n* Any severe concurrent disease, infection, or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry\n* Oral steroids e.g. prednisone \\>10 mg per day\n* History of active hepatitis B or C\n* Known history of HIV'}, 'identificationModule': {'nctId': 'NCT00700206', 'briefTitle': 'Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Telik'}, 'officialTitle': 'Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)', 'orgStudyIdInfo': {'id': 'TLK199.2101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '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.', 'interventionNames': ['Drug: Ezatiostat Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '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.', 'interventionNames': ['Drug: Ezatiostat Hydrochloride']}], 'interventions': [{'name': 'Ezatiostat Hydrochloride', 'type': 'DRUG', 'otherNames': ['Telintra', 'ezatiostat tablets'], 'description': '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.\n\nDose 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.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724-5024', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91801', 'city': 'Alhambra', 'state': 'California', 'country': 'United States', 'facility': 'Central Hematology Oncology Medical Group, Inc.', 'geoPoint': {'lat': 34.09529, 'lon': -118.12701}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Heritage Healthcare', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '91750', 'city': 'La Verne', 'state': 'California', 'country': 'United States', 'facility': 'Wilshire Oncology Medical Group, Inc.', 'geoPoint': {'lat': 34.10084, 'lon': -117.76784}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials and Research Associates, Inc.', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'North Valley Hematology/Oncology Medical Group', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '94523', 'city': 'Pleasant Hill', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Cancer Research Group', 'geoPoint': {'lat': 37.94798, 'lon': -122.0608}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Hematology Oncology Medical Group', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '92077', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Care Associates Medical Group, Inc.', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum Clinic', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Hematology Medical Group, Inc.', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Central Coast Medical Oncology Corporation', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '80445', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado at Denver Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'The Center for Hematology Oncology', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakeland Regional Cancer Center', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Cancer Care, LLC', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30045', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Suburban Hematology-Oncology Associates, P.C.', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Joliet Oncology-Hematology Associates, Ltd.', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Chicago', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '47802', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'Central Hematology Oncology Medical Group, Inc.', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Vincent's Comprehensive Cancer Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University/University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hematology & Medical Oncology', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'The University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Care Centers of South Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Gail Brown, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Telik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Telik', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}