FOLFIRINOX Plus IPI-926 for Advanced Pancreatic Adenocarcinoma
The purpose of this phase I study to determine the optimal dose for the combination of IPI-926 plus FOLFIRINOX (5-fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) chemotherapy in patients with pancreatic cancer.
Drug: FOLFIRINOX, IPI-926
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of FOLFIRINOX Plus IPI-926 for Advanced Pancreatic Adenocarcinoma|
- The maximum tolerated dose (MTD) for FOLFIRINOX plus IPI-926 in patients with advanced pancreatic cancer. [ Time Frame: Ongoing evaluation through sequential dose cohorts; evaluations at 2-week intervals up to one year. ] [ Designated as safety issue: Yes ]
- Number of participants with Adverse events and SAEs [ Time Frame: Ongoing evaluation for all patients throughout the course of treatment; evaluations at 2-week intervals up to one year. ] [ Designated as safety issue: Yes ]
- Time to tumor progression [ Time Frame: Efficacy evaluations at 2-month intervals up to one year. ] [ Designated as safety issue: No ]
- Objective response rate (ORR) by RECIST criteria [ Time Frame: Efficacy evaluations at 2-month intervals up to one year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Experimental: FOLFIRINOX Plus IPI-926||
Drug: FOLFIRINOX, IPI-926
Oxaliplatin: intravenous, 50 to 85 mg/m2, over 2 hrs, once per cycle.
Leucovorin: intravenous, 400 mg/m2, over 2 hrs, once per cycle.
Irinotecan: intravenous, 120 to 180 mg/m2, over 90 minutes, once per cycle.
5-FU: intravenous, 1600 to 2400mg/m2, over 46hr continuous infusion, once per cycle.
IPI-926: oral, 130 to 160 mg/day, daily, 14 days per cycle.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01383538
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Andrew Ko, M.D.||University of California, San Francisco|