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Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA (INSPIRE)


Title 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
Therapeutic Area Myelodysplastic Syndromes
Principal Investigator Kellie Sprague, MD
Min Age 18 Years
Max Age 81 Years
Gender Both
Contact Elizabeth Kendricken, RN
617-636-5558
More Information https://clinicaltrials.gov/ct2/show/NCT02562443

Overview

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).

Study Details

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Requirements

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.