Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
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| ClinicalTrials.gov Identifier: NCT00700206 |
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Recruitment Status :
Completed
First Posted : June 18, 2008
Last Update Posted : October 12, 2011
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Sponsor:
Telik
Information provided by (Responsible Party):
Telik
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myelodysplastic Syndrome (MDS) | Drug: Ezatiostat Hydrochloride | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 86 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS) |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | July 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Myelodysplastic Syndromes
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: 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 Names:
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Experimental: 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.
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Drug: 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 Names:
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Primary Outcome Measures :
- Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: 24 Weeks ]
Secondary Outcome Measures :
- Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments. [ Time Frame: 24 Weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Primary or de novo MDS
- 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:
- Prior allogenic bone marrow transplant for MDS
- 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
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): NCT00700206
Hide Study Locations
Locations
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724-5024 | |
| United States, California | |
| Central Hematology Oncology Medical Group, Inc. | |
| Alhambra, California, United States, 91801 | |
| St. Jude Heritage Healthcare | |
| Fullerton, California, United States, 92835 | |
| Wilshire Oncology Medical Group, Inc. | |
| La Verne, California, United States, 91750 | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| Clinical Trials and Research Associates, Inc. | |
| Montebello, California, United States, 90640 | |
| North Valley Hematology/Oncology Medical Group | |
| Northridge, California, United States, 91325 | |
| Bay Area Cancer Research Group | |
| Pleasant Hill, California, United States, 94523 | |
| Desert Hematology Oncology Medical Group | |
| Rancho Mirage, California, United States, 92270 | |
| Cancer Care Associates Medical Group, Inc. | |
| Redondo Beach, California, United States, 92077 | |
| Sansum Clinic | |
| Santa Barbara, California, United States, 93105 | |
| Santa Barbara Hematology Medical Group, Inc. | |
| Santa Barbara, California, United States, 93105 | |
| Central Coast Medical Oncology Corporation | |
| Santa Maria, California, United States, 93454 | |
| United States, Colorado | |
| University of Colorado at Denver Health Sciences Center | |
| Aurora, Colorado, United States, 80445 | |
| United States, Florida | |
| The Center for Hematology Oncology | |
| Boca Raton, Florida, United States, 33486 | |
| Lakeland Regional Cancer Center | |
| Lakeland, Florida, United States, 33805 | |
| Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Northeast Georgia Cancer Care, LLC | |
| Athens, Georgia, United States, 30607 | |
| Suburban Hematology-Oncology Associates, P.C. | |
| Lawrenceville, Georgia, United States, 30045 | |
| United States, Illinois | |
| Joliet Oncology-Hematology Associates, Ltd. | |
| Joliet, Illinois, United States, 60435 | |
| Loyola University Chicago | |
| Maywood, Illinois, United States, 60153 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62702 | |
| United States, Indiana | |
| Central Hematology Oncology Medical Group, Inc. | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Nevada | |
| Comprehensive Cancer Centers of Nevada | |
| Henderson, Nevada, United States, 89052 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| St. Vincent's Comprehensive Cancer Center | |
| New York, New York, United States, 10011 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Case Western Reserve University/University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Hematology & Medical Oncology | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| The University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Cancer Care Associates | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Cancer Care Associates | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Kaiser Permanente | |
| Portland, Oregon, United States, 97227 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Cancer Care Centers of South Texas | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Telik
Investigators
| Study Director: | Gail Brown, MD | Telik |
| Responsible Party: | Telik |
| ClinicalTrials.gov Identifier: | NCT00700206 History of Changes |
| Other Study ID Numbers: |
TLK199.2101 |
| First Posted: | June 18, 2008 Key Record Dates |
| Last Update Posted: | October 12, 2011 |
| Last Verified: | August 2011 |
Keywords provided by Telik:
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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 |
Additional relevant MeSH terms:
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Syndrome Myelodysplastic Syndromes Preleukemia Disease Pathologic Processes |
Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms |