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Onconova Announces Global Phase 3 INSPIRE Trial of Rigosertib in Higher-Risk Myelodysplastic Syndromes Enrollment of First Patient in Japan by SymBio

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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.    
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Catalyst Date
Occurred on:
Jul 19, 2016
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Related Keywords Higher-risk Myelodysplastic Syndromes, Rigosertib, Failure Of Hypomethylating Agent, Inspire Study, Azacitidine