FOLFIRINOX Plus IPI-926 for Advanced Pancreatic Adenocarcinoma
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|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|
|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 ]
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): 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|