The goal of this open-label, dose-escalation study is to establish the safety, maximum tolerated dose (MTD) and optimal schedule of administration for IPI-504 in combination with Taxotere. Initially, patients will receive 75mg/m2 of Taxotere followed by 300mg/m2 of IPI-504 on day one of each 21-day cycle. Once an MTD is reached, the trial will expand to enroll up to 20 additional patients. Additional schedules, including once-weekly dosing of IPI-504 and Taxotere, may also be explored as the trial progresses.
IPI-504, the companies’s lead heat shock protein 90 (Hsp90) inhibitor, is currently in clinical development for a number of solid tumor cancers. Enrollment for this new study has commenced at Memorial Sloan-Kettering Cancer Center in New York, with additional sites expected to be added as the study progresses.
David Grayzel, vice president, clinical development and medical affairs at Infinity, said: “This trial marks the first exploration of IPI-504 in combination with chemotherapy.”