IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol
The extension protocol is a continuation of treatment with IPI-926, as administered to each
individual patient during participation in their original IPI-926 protocol.
Patients who are completing their participation in the original IPI-926 protocol in which
they enrolled, as defined in the original protocol, and, have stable disease or confirmed
complete or partial response as defined by the original protocol may continue to receive
treatment with IPI-926 in the extension protocol.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results
Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926
Up to 30 days after the last patient study visit
Tess Schmalbach, MD
Infinity Pharmaceuticals, Inc.
United States: Food and Drug Administration
|University of Colorado Denver||Denver, Colorado 80262|
|Johns Hopkins||Baltimore, Maryland 21231|