Status:
COMPLETED
Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Telik
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00700206
Start Date
May 1 2008
End Date
July 1 2011
Last Update
October 12 2011
Active Locations (36)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
2
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States, 91801
3
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
4
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States, 91750