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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00700206
First received: June 13, 2008
Last updated: October 10, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Myelodysplastic Syndrome (MDS)
 Drug: Ezatiostat Hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Telik:

Primary Outcome Measures:
  • Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700206

  Show 36 Study Locations
Sponsors and Collaborators
Telik
Investigators
Study Director: Gail Brown, MD Telik
  More Information

No publications provided

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT00700206     History of Changes
Other Study ID Numbers: TLK199.2101
Study First Received: June 13, 2008
Last Updated: October 10, 2011
Health Authority: United States: Food and Drug Administration

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:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013