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

Locations

United States, California
Desert Hematology Oncology Medical Group	Recruiting
Rancho Mirage, California, United States, 92270
Contact: Nikkol Villarroel-Mitchell 760-568-3613 nikkolvillarroel@dc.rr.com
Principal Investigator: David E. Young, MD
Bay Area Cancer Research Group	Recruiting
Pleasant Hill, California, United States, 94523
Contact: Mary J Milligan 925-676-4740 ext 102 mmilligan@bacrg.com
Principal Investigator: Ostap G Melnyk, MD
Clinical Trials and Research Associates, Inc.	Recruiting
Montebello, California, United States, 90640
Contact: Azfar Siddiqui, CRC 323-271-1330 asiddiqui@beverlyoncology.com
Principal Investigator: Richy Agajanian, MD
Cancer Care Associates Medical Group, Inc.	Not yet recruiting
Redondo Beach, California, United States, 92077
Contact: Sherry Hutcherson, RN 310-750-3300
Principal Investigator: David Chan, MD
North Valley Hematology/Oncology Medical Group	Not yet recruiting
Northridge, California, United States, 91325
Contact: Pamela Riach, RN 818-773-6363
Principal Investigator: Sheldon Davidson, MD
UCLA Medical Center	Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Lynn Tihopu 310-794-0738 ltihopu@mednet.ucla.edu
Principal Investigator: Ron Paquette, MD
Santa Barbara Hematology Medical Group, Inc.	Not yet recruiting
Santa Barbara, California, United States, 93105
Contact: Gail Dayao 805-563-5800
Principal Investigator: Frederic C. Kass, MD
Sansum Clinic	Not yet recruiting
Santa Barbara, California, United States, 93105
Contact: Gail Dayao 805-898-3270
Principal Investigator: Julie Taguchi, MD
Central Coast Medical Oncology Corporation	Not yet recruiting
Santa Maria, California, United States, 93454
Contact: Alison Fernandez, RN 805-739-3724
Principal Investigator: Robert Dichmann, MD
Wilshire Oncology Medical Group, Inc.	Not yet recruiting
La Verne, California, United States, 91750
Contact: Odessa Rodriguez 909-495-5333
Principal Investigator: Linda D. Bosserman, MD
United States, Colorado
University of Colorado at Denver Health Sciences Center	Not yet recruiting
Aurora, Colorado, United States, 80445
Contact: Colleen Sonnhalter, RN 720-848-1246 Colleen.Sonnhalter@ucdenver.edu
Principal Investigator: Han Myint, MD
United States, Florida
Moffitt Cancer Center	Recruiting
Tampa, Florida, United States, 33612
Contact: Lisa Nardelli 813-745-4731 lisa.nardelli@moffitt.org
Principal Investigator: Alan List, MD
The Center for Hematology Oncology	Recruiting
Boca Raton, Florida, United States, 33486
Contact: Dolores Preiser, RN 561-416-8869 dpreiser@brch.com
Principal Investigator: Howard Adler, MD
Lakeland Regional Cancer Center	Recruiting
Lakeland, Florida, United States, 33805
Contact: Robin Stewart 863-904-1900 robin.stewart@LRMC.com
Principal Investigator: Madhavi L Venigalla, MD
United States, Georgia
Suburban Hematology-Oncology Associates, P.C.	Not yet recruiting
Lawrenceville, Georgia, United States, 30045
Contact: Kathy Frank 770-963-8030
Principal Investigator: Christopher Hagenstad, MD
United States, Illinois
Southern Illinois University School of Medicine	Recruiting
Springfield, Illinois, United States, 62702
Contact: Kathy Robinson, Phd 217-545-1946 krobinson@siumed.edu
Principal Investigator: John E Godwin, MD
Loyola University Chicago	Recruiting
Maywood, Illinois, United States, 60153
Contact: Eliza Germano, Rn, BSN 708-327-3317 egermano@lumc.edu
Principal Investigator: Scott E Smith, MD
Joliet Oncology-Hematology Associates, Ltd.	Recruiting
Joliet, Illinois, United States, 60435
Contact: Maureen Clennon, CRC/CRA 815-730-3098 MaureenC@jolietoncology.com
Principal Investigator: Sanjiv Modi, MD
United States, Indiana
Providence Medical Group	Not yet recruiting
Terre Haute, Indiana, United States, 47802
Contact: Kim Villain, RN 812-232-1418
Principal Investigator: Sang Huh, MD
United States, Maryland
Center for Cancer and Blood Disorders	Recruiting
Bethesda, Maryland, United States, 20817
Contact: Natalie Bongiorno, RN, MSHS 301-570-2016 nbongiorno@ccbdmd.com
Principal Investigator: Ralph Boccia, MD
United States, New Jersey
Cancer Institute of New Jersey	Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Binaifer Balsara 732-235-9837 beeral@umdnj.edu
Principal Investigator: Dale Schaar, MD
United States, New York
St. Vincent's Comprehensive Cancer Center	Recruiting
New York, New York, United States, 10011
Contact: Murtaza Mehdi 212-361-0190 mmehdi@apiumoncology.com
Principal Investigator: Azra Raza, MD
United States, Oklahoma
The University of Oklahoma Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Sharon Porter, CCRP 405-271-4022 Sharon-Porter@ouhsc.edu
Principal Investigator: Howard Ozer, MD
United States, Oregon
Kaiser Permanente	Recruiting
Portland, Oregon, United States, 97227
Contact: Michelle M Jones 503-249-3329 michelle.marie.jones@kpchr.org
Principal Investigator: Mark Rarick, MD
United States, Texas
MD Anderson Cancer Center	Not yet recruiting
Houston, Texas, United States, 77030
Contact: Anne Strickland 713-745-4613 astrickl@mdanderson.org
Principal Investigator: Stefan Faderl, MD

Sponsors and Collaborators

Telik

Investigators

Study Director:

Gail Brown, MD

Telik

More Information

Responsible Party:	Telik, Inc. ( Gail Brown, MD Chief Medical Officer )
Study ID Numbers:	TLK199.2101
Study First Received:	June 13, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00700206
Health Authority:	United States: Food and Drug Administration

Keywords provided by Telik:

Hematology

Study placed in the following topic categories:

Myelodysplastic syndromes
Preleukemia
Precancerous Conditions
Hematologic Diseases

Myelodysplasia
Myelodysplastic Syndromes
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009