Dose limiting toxicities (DLTs) of Grade 3 diarrhea and Grade 4 hyperglycemia were reported in 1 patient at the 60 mg QD dose. Treatment-related serious adverse events (AEs) of Grade 3 epistaxis (30 mg QD, n=1), and Grade 3 diarrhea and Grade 4 hyperglycemia (60 mg QD, n=1) were also reported with the daily schedule. To date, the most frequent (reported in ≥ 2 patients) Grade 3 or 4 AEs include thrombocytopenia, diarrhea and neutropenia, thus far only with the QD administration schedule. Toxicities have limited the ability to further dose escalate using the QD schedule. By contrast, no DLTs or dose interruptions have been reported for patients enrolled onto the BIW regimen at the 60mg dose level.Eleven of the 13 patients included in the ASH presentation were evaluable for response assessment per protocol. One of these patients had mixed follicular lymphoma/ diffuse large B cell lymphoma and achieved a PR (70% reduction in a single target lesion) at the 30 mg QD dose level. Seven other patients have met criteria for SD, including 4 with SD lasting at least 4 cycles of treatment. One of these patients (MM) is currently in Cycle 13.
Curis Reports CUDC-907 Preliminary Data From The Ongoing Phase 1 Trial At ASH 2013 Annual Meeting
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