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

Primary Purpose

Myelodysplastic Syndrome (MDS)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ezatiostat Hydrochloride
Sponsored by
Telik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Cancer Center
  • Central Hematology Oncology Medical Group, Inc.
  • St. Jude Heritage Healthcare
  • Wilshire Oncology Medical Group, Inc.
  • UCLA Medical Center
  • Clinical Trials and Research Associates, Inc.
  • North Valley Hematology/Oncology Medical Group
  • Bay Area Cancer Research Group
  • Desert Hematology Oncology Medical Group
  • Cancer Care Associates Medical Group, Inc.
  • Sansum Clinic
  • Santa Barbara Hematology Medical Group, Inc.
  • Central Coast Medical Oncology Corporation
  • University of Colorado at Denver Health Sciences Center
  • The Center for Hematology Oncology
  • Lakeland Regional Cancer Center
  • Moffitt Cancer Center
  • Northeast Georgia Cancer Care, LLC
  • Suburban Hematology-Oncology Associates, P.C.
  • Joliet Oncology-Hematology Associates, Ltd.
  • Loyola University Chicago
  • Southern Illinois University School of Medicine
  • Central Hematology Oncology Medical Group, Inc.
  • Center for Cancer and Blood Disorders
  • Comprehensive Cancer Centers of Nevada
  • Cancer Institute of New Jersey
  • St. Vincent's Comprehensive Cancer Center
  • University of Rochester Medical Center
  • Case Western Reserve University/University Hospitals of Cleveland
  • Hematology & Medical Oncology
  • The University of Oklahoma Health Sciences Center
  • Cancer Care Associates
  • Cancer Care Associates
  • Kaiser Permanente
  • MD Anderson Cancer Center
  • Cancer Care Centers of South Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm 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.

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.

Outcomes

Primary Outcome Measures

Hematologic Improvement-Erythroid (HI-E) rate

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.

Full Information

First Posted
June 13, 2008
Last Updated
October 10, 2011
Sponsor
Telik
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1. Study Identification

Unique Protocol Identification Number
NCT00700206
Brief Title
Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telik

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome (MDS)
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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.
Arm Title
2
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ezatiostat Hydrochloride
Other Intervention Name(s)
Telintra, ezatiostat tablets
Intervention 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. 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.
Primary Outcome Measure Information:
Title
Hematologic Improvement-Erythroid (HI-E) rate
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Brown, MD
Organizational Affiliation
Telik
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Central Hematology Oncology Medical Group, Inc.
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
St. Jude Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Wilshire Oncology Medical Group, Inc.
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Clinical Trials and Research Associates, Inc.
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
North Valley Hematology/Oncology Medical Group
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Bay Area Cancer Research Group
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Desert Hematology Oncology Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Cancer Care Associates Medical Group, Inc.
City
Redondo Beach
State/Province
California
ZIP/Postal Code
92077
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Santa Barbara Hematology Medical Group, Inc.
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
University of Colorado at Denver Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80445
Country
United States
Facility Name
The Center for Hematology Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northeast Georgia Cancer Care, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Suburban Hematology-Oncology Associates, P.C.
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Ltd.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Central Hematology Oncology Medical Group, Inc.
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Case Western Reserve University/University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Hematology & Medical Oncology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cancer Care Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Kaiser Permanente
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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