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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014