A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)|
- Overall response rate (ORR) in all subjects during treatment with IPI-145 based on standard response. [ Time Frame: Every 8-16 weeks while on treatment with IPI-145; an expected average on-treatment duration of response follow-up of 24 months ]
- Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values [ Time Frame: Every 2-8 weeks; up to 30 days after the last dose of IPI-145 ]
- Duration of Response [ Time Frame: Every 8-16 weeks; for an average duration of response follow-up of 24 months ]
- Progression-free survival [ Time Frame: Every 8-16 weeks; for an average response / progression follow-up of 24 months ]
- Overall survival [ Time Frame: Every 16 weeks; for an average survival follow-up of 24 months ]
- PK Plasma concentrations of IPI-145 and its metabolite(s) [ Time Frame: Every 4 weeks for 12 weeks ]
- Time to response (TTR) [ Time Frame: First dose to first documentation of complete or partial response ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||January 2018|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
This is an open-label, single arm safety and efficacy study of IPI-145 administered orally to subjects who have been diagnosed with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma) whose disease is refractory to rituximab and to either chemotherapy or RIT.
Approximately 120 subjects will receive 25 mg IPI-145 BID over the course of 28-day treatment cycles for up to 13 cycles.
After completing 13 treatment cycles of IPI-145, subjects may continue to receive additional cycles of IPI-145 until disease progression or unacceptable toxicity. However, to receive additional cycles of IPI-145 beyond 13 cycles, subjects must have evidence of response (CR or PR) according to the IWG criteria1 by the end of Cycle 13.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882803
Show 67 Study Locations
|Study Chair:||Hagop Youssoufian, MD||Verastem, Inc.|