FOLFIRINOX Plus IPI-926 for Advanced Pancreatic Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT01383538|
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : August 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Adenocarcinoma Pancreatic Neoplasms||Drug: FOLFIRINOX, IPI-926||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of FOLFIRINOX Plus IPI-926 for Advanced Pancreatic Adenocarcinoma|
|Actual Study Start Date :||August 23, 2011|
|Actual Primary Completion Date :||December 13, 2012|
|Actual Study Completion Date :||May 26, 2015|
|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.
- 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. ]
- 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. ]
- Time to tumor progression [ Time Frame: Efficacy evaluations at 2-month intervals up to one year. ]
- Objective response rate (ORR) by RECIST criteria [ Time Frame: Efficacy evaluations at 2-month intervals up to one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|