Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine
NCT01928537 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2020-06-30
Summary
This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine.
Conditions
- Myelodysplastic Syndromes
- Refractory Anemia With Excess Blasts
- Chronic Myelomonocytic Leukemia
- Cytopenia
Interventions
- DRUG
-
rigosertib sodium
Sponsors & Collaborators
-
Traws Pharma, Inc.
lead INDUSTRY
Principal Investigators
-
Steven M. Fruchtman, MD · Traws Pharma, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-08-31
- Primary Completion
- 2017-06-29
- Completion
- 2017-06-29
Countries
- United States
- Australia
- Denmark
- France
- Germany
- Italy
- Spain
- Sweden
Study Locations
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