For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
IRX5183 will be administered orally daily on days 1-28 of each cycle for 2 cycles of induction. In the phase I part of the study, there will be 3 dose levels (dose level 1 [DL1] with 50 mg, DL2 with 75 mg, and DL3 with 100 mg), with 1 additional dose level to be only used if excessive toxicity noted at the DL1. There will be no intra-patient dose escalation.
In the phase II part of the study, the investigators will use the optimal dose identified in phase I and will aim to recruit a total of 27 patients per a Simon's 2 stage design. After induction, all patients who do not experience significant toxicity or disease progression will continue on a consolidation/maintenance phase of the study in which 4 additional 28-day cycles of IRX5183 will be administered. This phase will use the same dose used in the induction phase for each individual patient.