Onconova expands enrollment in Phase III INSPIRE trial of rigosertib in MDS

Onconova Therapeutics Inc. (NASDAQ:ONTX) said it will expand enrollment in the Phase III INSPIRE trial of IV rigosertib (Estybon, SyB L-1101, ON 01910.Na) to treat higher-risk myelodysplastic syndrome (MDS) in patients who progressed on, failed to respond to or relapsed after treatment with a hypomethylating agent. Target enrollment in the open-label, international trial will increase to 360 from 225 patients. An IDMC recommended the expansion after an interim analysis.

Under INSPIRE's adaptive design, the interim analysis was designed to determine whether the trial should continue as planned, discontinue for futility, expand according to a prespecified sample size re-estimation or continue only in a predefined subgroup of very high-risk patients...