Additional Relevant Details
The INSPIRE trial is a multi-center, randomized controlled Phase 3 study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed, following previous treatment with HMAs. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care. It is anticipated that more than 130 sites across four continents (North America, Europe, Australia and Asia) will participate in this trial. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated.