IPI-926 Extension Protocol for Continuation of Treatment With IPI-926
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|ClinicalTrials.gov Identifier: NCT01609179|
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : November 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma Chondrosarcoma||Drug: IPI-926||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||November 2012|
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
- 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 ]Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|