A Phase 2 Study of IPI-145 in Subjects With Refractory Indolent Non-Hodgkin Lymphoma
This is an open-label, single arm safety and efficacy study of IPI-145 administered orally
to subjects who have been diagnosed with iNHL (FL, MZL, or SLL) whose disease is refractory
to rituximab and chemotherapy in combination or RIT.
Approximately 120 subjects will receive 25 mg IPI-145 BID over the course of 28-day
treatment cycles for up to 12 cycles.
After completing 12 treatment cycles of IPI-145, subjects may continue to receive additional
cycles of IPI-145 for up to a total of 2 years of treatment. However, to receive additional
cycles of IPI-145 beyond 12 cycles, subjects must have evidence of response (CR or PR)
according to the IWG criteria1 by the end of Cycle 12.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (ORR) in all subjects during treatment with IPI-145 based on standard response.
Every 8-16 weeks while on treatment with IPI-145; an expected average on-treatment duration of response follow-up of 20 months
Patrick Kelly, MD
Infinity Pharmaceuticals, Inc.
United States: Food and Drug Administration
|Nashville, Tennessee 37203-1632|