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Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA (INSPIRE)
||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
||Kellie Sprague, MD
||Elizabeth Kendricken, RN
The primary objective of this study is to compare the overall survival (OS) of patients receiving intravenous (IV) rigosertib to the OS of patients receiving the physician’s choice of treatment (PC) in a population of patients with myelodysplastic syndrome (MDS) after failure of treatment with a hypomethylating agent (HMA), azacitidine (AZA) or decitabine (DEC).
- Must have Myelodysplastic Syndrome (MDS)
- Must have failed a hypomethylating agent, decitabine or azacitidine
- Must have failed to respond to, relapsed following, not eligible for, or opted not to participate in allogeneic stem cell transplantation
- Must not have previously received rigosertib
- Must not have received treatment for MDS within 4 weeks to starting protocol treatment
Must not be pregnant or breastfeeding
Subjects will be required to come to Tufts Medical Center once a day for the 72 hour treatment period or stay inpatient, upon the investigator's discretion.Up to a teaspoon of extra blood will be required of subjects during screening, and every 2 weeks until disease progression. Bone marrow biopsies will be performed at screening, end of treatment, and every 8 weeks during treatment until disease progression.