A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

Protocol: 
AAAP9823
Phase: 
III

A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

The purpose of this study is to determine how well a drug called rigosertib works on people with MDS and to study the safety of rigosertib when it is given to people with MDS. Rigosertib is currently being tested in other clinical research studies.

Are you Eligible? (Inclusion Criteria)

1.18-79 years of age
2. MDS classified as follows, according to WHO criteria (Appendix 2) or
modified FAB classification (Appendix 3):
• RAEB-1 (5% to 9% BM blasts)
• RAEB-2 (10% to 19% BM blasts)
• RAEB-t (20% to 30% BM blasts)
3. Diagnosis of MDS confirmed within 8 weeks prior to the Screening Visit
4. At least one cytopenia (ANC < 1800/μL or platelet count < 100,000/μL or
hemoglobin [Hgb] <10 g/dL)

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States