CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03699319|
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: CPI 613||Phase 2|
The objective of this study is to determine if CPI-613 increases overall survival (OS) when used in combination with modified FOLFIRINOX (mFOLFIRINOX), in participants with locally advanced pancreatic cancer and to assess the safety of CPI-613 + mFOLFIRINOX combination in participants with locally advanced pancreatic cancer. The study team would like to collect tissue specimens for future correlative studies and aim to estimate median progression free survival (PFS) and the percent resected when CPI-613 is used in combination with mFOLFIRINOX, in participants with locally advanced pancreatic cancer.
This is a single-armed study of participants with locally advanced pancreatic cancer, evaluating combination CPI-613 with modified FOLFIRINOX. Participants will be accrued at University Hospitals Cleveland Medical Center over 24 months with data analysis, and concluded 12 months after last accrual. Approximately 33 subjects will be enrolled in this trial, and the total duration of therapy is 6 months. All participants will be followed until death or 3 years from the completion of the study. The study team expects to complete accrual in 24 months, and will analyze data 12 months after accrual completion. The study will be completed 12 months after accrual completion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-armed study of patients with locally advanced pancreatic cancer, evaluating combination CPI-613 with modified FOLFIRINOX|
|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|
|Actual Study Start Date :||December 4, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
Experimental: CPI-613 + modified FOLFIRINOX
Novel drug and mitochondrial inhibitor, CPI-613 in conjunction with standard-of-care FOLFRINOX.
Drug: CPI 613
CPI-613, 500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port on days 1 and 3, every 2 weeks.
Other Name: 6, 8-bis-benzylsulfanyloctanoic acid
- Overall Survival [ Time Frame: Three years after start of study ]Interval between enrollment and death
- Progression free survival (PFS) [ Time Frame: Three years after start of study ]Time from study enrollment to progression or death from any cause
- Time to progression (TTP) [ Time Frame: Three years after start of study ]Time from enrollment to progression
- RECIST version 1.1 response rates [ Time Frame: Three years after start of study ]RECIST version 1.1 response rates including complete response, partial response and stable disease (CR+PR+SD)
- Complete pathologic response rates (CRp) [ Time Frame: Three years after start of study ]
- Resection margins [ Time Frame: Three years after start of study ]
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): NCT03699319
|Contact: Erin Anderson, RNfirstname.lastname@example.org|
|United States, Ohio|
|University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Jeffrey Hardacre, MD 800-641-2422 CTUReferral@uhhospitals.org|
|Principal Investigator:||Jeffery Hardacre, MD||University Hospitals Cleveland Medical Center|