IPI-926 Extension Protocol for Continuation of Treatment With IPI-926
A treatment protocol that enables patients to have continued access to IPI-926.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol|
- Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results [ Time Frame: Up to 30 days after the last patient study visit ] [ Designated as safety issue: No ]Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926
|Study Start Date:||March 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
IPI-926 is administered orally as a capsule formulation, as a fixed dose in mg/day. Patients will be administered the same dose with same cycle length of IPI-926 and combination therapy that they were receiving in the original protocol at the time of transition into the extension study. The following are potential once-daily doses that patients are receiving in original protocols: 60 mg, 90 mg, 100 mg, 110 mg, 130 mg, or 160 mg.
Other Name: saridegib
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609179
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|United States, Maryland|
|Baltimore, Maryland, United States, 21205|
|Study Director:||Tess Schmalbach, MD||Infinity Pharmaceuticals, Inc.|