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Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)

Sponsor
Telik (Industry)
Overall Status
Completed
CT.gov ID
NCT00700206
Collaborator
(none)
86
Enrollment
36
Locations
2
Arms
38
Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Ezatiostat Hydrochloride
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 1, 2008
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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.

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:
  • Telintra
  • ezatiostat tablets

    		•
    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.

    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:
  • Telintra
  • ezatiostat tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hematologic Improvement-Erythroid (HI-E) rate [24 Weeks]

    Secondary Outcome Measures

    1. Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments. [24 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 85724-5024
    2 Central Hematology Oncology Medical Group, Inc. Alhambra California United States 91801
    3 St. Jude Heritage Healthcare Fullerton California United States 92835
    4 Wilshire Oncology Medical Group, Inc. La Verne California United States 91750
    5 UCLA Medical Center Los Angeles California United States 90095
    6 Clinical Trials and Research Associates, Inc. Montebello California United States 90640
    7 North Valley Hematology/Oncology Medical Group Northridge California United States 91325
    8 Bay Area Cancer Research Group Pleasant Hill California United States 94523
    9 Desert Hematology Oncology Medical Group Rancho Mirage California United States 92270
    10 Cancer Care Associates Medical Group, Inc. Redondo Beach California United States 92077
    11 Sansum Clinic Santa Barbara California United States 93105
    12 Santa Barbara Hematology Medical Group, Inc. Santa Barbara California United States 93105
    13 Central Coast Medical Oncology Corporation Santa Maria California United States 93454
    14 University of Colorado at Denver Health Sciences Center Aurora Colorado United States 80445
    15 The Center for Hematology Oncology Boca Raton Florida United States 33486
    16 Lakeland Regional Cancer Center Lakeland Florida United States 33805
    17 Moffitt Cancer Center Tampa Florida United States 33612
    18 Northeast Georgia Cancer Care, LLC Athens Georgia United States 30607
    19 Suburban Hematology-Oncology Associates, P.C. Lawrenceville Georgia United States 30045
    20 Joliet Oncology-Hematology Associates, Ltd. Joliet Illinois United States 60435
    21 Loyola University Chicago Maywood Illinois United States 60153
    22 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    23 Central Hematology Oncology Medical Group, Inc. Terre Haute Indiana United States 47802
    24 Center for Cancer and Blood Disorders Bethesda Maryland United States 20817
    25 Comprehensive Cancer Centers of Nevada Henderson Nevada United States 89052
    26 Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    27 St. Vincent's Comprehensive Cancer Center New York New York United States 10011
    28 University of Rochester Medical Center Rochester New York United States 14642
    29 Case Western Reserve University/University Hospitals of Cleveland Cleveland Ohio United States 44106
    30 Hematology & Medical Oncology Cleveland Ohio United States 44195
    31 The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    32 Cancer Care Associates Oklahoma City Oklahoma United States 73112
    33 Cancer Care Associates Tulsa Oklahoma United States 74136
    34 Kaiser Permanente Portland Oregon United States 97227
    35 MD Anderson Cancer Center Houston Texas United States 77030
    36 Cancer Care Centers of South Texas San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Telik

    Investigators

    • Study Director: Gail Brown, MD, Telik

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Telik
    ClinicalTrials.gov Identifier:
    NCT00700206
    Other Study ID Numbers:
    • TLK199.2101
    First Posted:
    Jun 18, 2008
    Last Update Posted:
    Oct 12, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by Telik
    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:
    Preleukemia
    Myelodysplastic Syndromes
    Syndrome

    Study Results

    No Results Posted as of Oct 12, 2011