CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03374852|
Recruitment Status : Withdrawn (PI Left institution on 8/6/2018 and study has been final reported with IRB. Never opened to accrual)
First Posted : December 15, 2017
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Ductal Adenocarcinoma||Drug: CPI-613 Drug: mFOLFIRNOX||Phase 2|
1) To determine if CPI-613 increases overall survival (OS) when used in combination with mFOLFIRINOX, in patients with locally advanced pancreatic cancer.
Secondary (Exploratory) Objectives:
- To assess the safety of CPI-613 + mFOLFIRINOX combination in patients with locally advanced pancreatic cancer.
- To collect tissue specimens for future correlative studies
- To estimate median progression free survival (PFS) when CPI- 613 is used in combination with mFOLFIRINOX, in patients with locally advanced pancreatic cancer.
- To estimate the percent resected when CPI-613 is used in combination with mFOLFIRINOX in patients with locally advanced pancreatic cancer
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Open-Label Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer and Good Performance Status|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||October 5, 2019|
|Estimated Study Completion Date :||October 2020|
Experimental: CPI-613 + mFOLFIRNOX
CPI-613: 500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port mFOLFIRNOX (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2-hr IV infusion via a central venous port
500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port
mFOLFIRNOX (given immediately after CPI-613 administration):
- Overall Survival [ Time Frame: Enrollment to death ]Overall survival defined as the interval between enrollment and death.
- Progression free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]Progression free survival time is defined as time from enrollment until progression or death. The distribution of PFS will be estimated using the Kaplan-Meier method.
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): NCT03374852
|Principal Investigator:||Jordan Winter, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|