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

Sponsor:	Telik
Information provided by (Responsible Party):	Telik
ClinicalTrials.gov Identifier:	NCT00700206

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 II

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:

MedlinePlus related topics: Myelodysplastic Syndromes

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 February 09, 2012