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CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03699319
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Hardacre, Case Comprehensive Cancer Center

Brief Summary:
The purpose of this study is to treat participants with the combination of CPI-613 (the study drug) with FOLFIRINOX (the standard combination of drugs) to determine if it is safe and effective for participants with localized and unresectable pancreatic cancer. This study is specifically for participants who have a pancreatic cancer that is localized and not considered resectable or removable by a surgeon, without additional treatment.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: CPI 613 Phase 2

Detailed Description:

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.


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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Three years after start of study ]
    Interval between enrollment and death


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Three years after start of study ]
    Time from study enrollment to progression or death from any cause

  2. Time to progression (TTP) [ Time Frame: Three years after start of study ]
    Time from enrollment to progression

  3. 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)

  4. Complete pathologic response rates (CRp) [ Time Frame: Three years after start of study ]
  5. Resection margins [ Time Frame: Three years after start of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have histologically or cytologically confirmed pancreatic adenocarcinoma.
  • Subjects must have locally advanced (including unresectable or borderline resectable) pancreatic cancer based on CT or MRI imaging (pancreas protocol CT of the abdomen and pelvis if possible, MRI with contrast or CT with oral and IV contrast in the absence of a pancreas protocol CT scan, CT of the chest with or without contrast) as determined by the PI or Co-investigators. Patients with contrast allergies may be permitted without contrast scans if approved by the PI or Co-Investigators for safety reasons.
  • Eastern Cooperative Oncology Group (ECOG) Performance status being 01 within 1 week of planned start of therapy.
  • Subjects must have normal organ and marrow function as defined below < 2 weeks must be:
  • Adequate hematologic (white blood cell [WBC] >= 3500 cells/mm3; platelet count >= 100,000 cells/mm3; absolute neutrophil count [ANC] >=1500 cells/mm3; and hemoglobin >=8 g/dL).
  • Adequate hepatic function (aspartate aminotransferase [AST/SGOT] 3x upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] <=3x UNL, bilirubin <=1.5x UNL).
  • Adequate renal function (serum creatinine <=2.0 mg/dL or 177 µmol/L).
  • Adequate coagulation ("International Normalized Ratio" or INR must be <1.5) unless on therapeutic blood thinners.
  • Expected survival >=3 months in the view of the PI or investigators.
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
  • Fertile men must practice effective contraceptive methods (i.e. surgical sterilization, or a condom used with a spermicide) during the study, unless documentation of infertility exists.
  • No evidence of clinically significant active infection and no serious infection within the past month requiring hospitalization.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment.

  • Subjects under the age of 18 or older than 80 years of age.
  • Subjects with endocrine or acinar pancreatic carcinoma.
  • Subjects with resectable pancreatic cancer.
  • Subjects with metastatic pancreatic cancer based on imaging.
  • Subjects who have received prior surgical or medical treatment for pancreatic cancer.
  • Subjects receiving any other standard or investigational treatment for their cancer with a primary goal of improving survival within the past 2 weeks prior to initiation of CPI-613 treatment.
  • Pregnant women or breast feeding women, or women of child-bearing potential not using reliable means of contraception are excluded from this study because the teratogenic or abortifacient effects of CPI-613 is unknown. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CPI-613, breastfeeding should be discontinued if the mother is treated with CPI-613. These potential risks may also apply to other agents used in this study.
  • Fertile men unwilling to practice contraceptive methods during the study period.
  • Subjects with a life expectancy less than 3 months.
  • Subjects with a serious medical illness that would potentially increase subjects' risk for toxicity
  • Subjects with any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
  • Subjects with a history of myocardial infarction that is <3 months prior to registration.
  • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure or coronary artery disease, unstable angina pectoris, cardiac arrhythmia, symptomatic myocardial infarction or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects who are known to be HIV-positive and on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with CPI-613.

Information from the National Library of Medicine

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


Contacts
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Contact: Sarah Housour 1-800-641-2422 sarah.housour@uhhospitals.org

Locations
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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    cancer@case.edu   
United States, Pennsylvania
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Harish Lavu, MD FACS    215-955-9402    Harish.Lavu@jefferson.edu   
Sponsors and Collaborators
Jeffrey Hardacre
Investigators
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Principal Investigator: Jeffery Hardacre, MD University Hospitals Cleveland Medical Center

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Responsible Party: Jeffrey Hardacre, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03699319     History of Changes
Other Study ID Numbers: CASE2218
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey Hardacre, Case Comprehensive Cancer Center:
FOLFIRINOX
CPI-613

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases