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

June 13, 2008
October 10, 2011
May 2008
July 2011   (final data collection date for primary outcome measure)
Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00700206 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndrome (MDS)
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: 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.
    Intervention: Drug: Ezatiostat Hydrochloride
  • 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.
    Intervention: Drug: Ezatiostat Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00700206
TLK199.2101
No
Telik
Telik
Not Provided
Study Director: Gail Brown, MD Telik
Telik
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP