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

Sponsored by:	Telik
Information provided by:	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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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)

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
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose Schedule 1: Two weeks treatment with Telintra followed by one week with no treatment per three week cycle.	Drug: Ezatiostat Hydrochloride 4500 mg orally per day in two divided doses
2: Experimental Dose Schedule 2: Three weeks treatment with Telintra followed by one week with no treatment per four week cycle.	Drug: Ezatiostat Hydrochloride 4500 mg orally per day in two divided doses

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

Contacts

Contact: David Tesarowski, PhD

650-845-7765

dtesarowski@telik.com

Show 35 Study Locations

Sponsors and Collaborators

Telik

Investigators

Study Director:

Gail Brown, MD

Telik

More Information

No publications provided

Responsible Party:	Telik, Inc. ( Gail Brown, MD Chief Medical Officer )
Study ID Numbers:	TLK199.2101
Study First Received:	June 13, 2008
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00700206 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Telik:

Hematology

Study placed in the following topic categories:

Preleukemia
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Preleukemia
Pathologic Processes
Disease
Precancerous Conditions

Hematologic Diseases
Syndrome
Myelodysplastic Syndromes
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 07, 2009