Trial Period
11/09/2018 - 03/2022
Conditions
Metastatic Pancreatic Cancer Pancreatic Cancer
(14) Trial Site Locations
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Clinical Trial PANC003: Patients with Metastatic Adenocarcinoma of the Pancreas

Trial ID: PANC003 | NCT03504423

SUMMARY: A Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of FOLFIRINOX (FFX) versus Combination of CPI-613 with modified FOLFIRINOX (mFFX) in Patients with Metastatic Adenocarcinoma of the Pancreas

Trial Details

  • Gender(s)
  • 3 Phase
  • 18-75 Age Range
  • 14 Locations
  • Recruiting
Trial Period
11/09/2018 - 03/2022
Conditions
Metastatic Pancreatic Cancer Pancreatic Cancer
(14) Trial Site Locations
View on Map

For Patients

Get information about indications and participating in clinical trials that match your diagnoses.

More Info

For Physicians

Learn about treatments and read the latest news and resources for health professionals.

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Treatment Options

Study Arms Assigned Intervention
Arm 1: CPI-613 and modified Folfirinox Drugs: CPI-613, mFolfirinox (5-fluoruracil, leucovorin, irinotecan, oxaliplatin)
Arm 2: Folfirinox Drugs: Folfirinox (5-fluoruracil, leucovorin, irinotecan, oxaliplatin)

Key Eligibility Criteria

Inclusion

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
  2. No prior treatments for stage IV pancreatic adenocarcinoma (prior adjuvant or neoadjuvant treatment is allowed provided completed ≥ 6 months prior to disease recurrence)
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0 – 117
  4. Male and female patients 18 – 75 years of age
  5. Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
  6. Expected survival >3 months
  7. 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(s), intrauterine hormone releasing system (IUS),
    bilateral tubal occlusion or vasectomized partner) during and for 6 months of the study and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation, at the end of systemic exposure and between the cycles if
    the menstrual period is delayed by over 30 days.
  8. Adult subjects of childbearing potential must agree to use double barrier contraceptive measure, oral contraception or avoidance of intercourse during the study and for 6 months after last study dose is received.
  9. At least 2 weeks must have elapsed from any prior surgery with resolution of any sequela for randomization
  10. Laboratory values ≤2 weeks prior to randomization must be:
    1. Adequate hematologic values:
      1. Platelet count ≥100,000 cells/mm3 or ≥100 bil/L;
      2. Absolute neutrophil count [ANC] ≥1,500 cells/mm3 or ≥1.5 bil/L;
      3. Hemoglobin ≥9 g/dL or ≥90 g/L)
    2. Adequate hepatic function:
      1. Aspartate aminotransferase [AST/SGOT] ≤3x upper normal limit [UNL]
      2. Alanine aminotransferase [ALT/SGPT] ≤3x UNL (≤5x UNL if liver metastases present)
      3. Bilirubin ≤1.5x UNL); does not apply to subjects with Gilbert’s syndrome
      4. Serum albumin > 3.0 g/dL
    3. Adequate renal function:
      1. Serum creatinine clearance CLcr > 30 mL/min
    4. Adequate coagulation function:
      1. International Normalized Ratio or INR must be <1.5 unless on therapeutic blood thinners)
  11. No evidence of active infection and no serious infection within the past 30 days
  12. Mentally competent, ability to understand and willingness to sign the informed consent form
Exclusion

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Endocrine or acinar pancreatic carcinoma
  2. Known cerebral metastases, central nervous system (CNS), or epidural tumor
  3. Prior treatment with any chemotherapy for metastatic adenocarcinoma of the pancreas
  4. Completion of a gemcitabine-based adjuvant chemotherapy regimen within less than 6 months at the time of screening
  5. Receipt of neoadjuvant or adjuvant FOLFIRINOX therapy
  6. Presence of clinically significant abdominal ascites
  7. Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment
  8. Serious medical illness that would potentially increase patients’ risk for toxicity
  9. Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
  10. NAP
  11. Lactating females
  12. Fertile men unwilling to practice contraceptive methods during the study period
  13. Life expectancy less than 3 months
  14. Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
  15. Unwilling or unable to follow protocol requirements
  16. Active heart disease including but not limited to symptomatic congestive heart failure (NYHA class 3 or 4), symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction
  17. Patients with a history of myocardial infarction that is <3 months prior to registration
  18. Evidence of active infection, or serious infection within the past 30 days
  19. Patients with known HIV infection
  20. Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment (steroids given for supportive care or in response to allergic reactions are allowed at any time)
  21. Requirement for immediate palliative treatment of any kind including surgery
  22. No prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated cancer from which the patient has been disease-free for at least 3 years prior to
    screening
  23. Unwilling or unable to avoid the concomitant use of strong CYP3A4 inducers or inhibitors during treatment with irinotecan
  24. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 480 milliseconds (ms) (CTCAE grade 1) using Fredericia’s QT correction formula (i.e. QTcF)
  25. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of long QT syndrome)
  26. The use of concomitant medications that prolong the QT/QTc intervals

Trial Site Locations (14)

View All Locations
Atlantic Health System Cancer Center 100 Madison Ave
Morristown, NJ 07962
USA
Contact Info: Nancy Ginder (973) 971-6608 nancy.ginder@atlantichealth.org
University of Pittsburgh Medical Center 5115 Centre Ave
Pittsburgh, PA 15232-1301
US
Contact Info: Wendy Lane-Scott (412) 864-7688 lanewg@upmc.edu
NYU Langone Health 550 1st Ave
New York, NY 10016
US
Contact Info: Cheala Harrison (212) 731-6127 cheala.harrison@nyumc.org
Georgetown University Medical Center 3800 Reservoir Road NW
Washington, DC 20007
US
Contact Info: Nicole Villa (202) 687-7606 nv209@georgetown.edu
Wake Forest Baptist Medical Center 1475 NW 12th Ave
Winston-Salem, NC 27157
US
Contact Info: Destini Butler (336) 713-4416 dtbutler@wakehealth.edu
Levine Cancer Institute Atrium Health 1021 Morehead Medical Dr
Charlotte, NC 28204
US
Contact Info: Jenna Gregory jenna.gregory@atriumhealth.org
Ingalls Cancer Center 71 W 156th St
Ste 401
Harvey, Illinois 60426-4265
US
Contact Info: Margaret Marriott (708) 915-6119 mmariot@ingalls.org
University Hospitals – Seidman Cancer Center 11100 Euclid Avenue
Cleveland, Ohio 44106
USA
Contact Info: Erin Anderson 216-863-3839 erin.anderson@uhhospitals.org
University of New Mexico Cancer Center 1201 Camino de Salud
Albuquerque, NM 87102
USA
Contact Info: Denise Buchanan 505-925-4946 dbuchanan@salud.unm
University of Utah – Huntsman Cancer Institute 2000 Circle of Hope
Salt Lake, Utah 84112
USA
Contact Info: Arun Athithan 801-587-4624 arun.athithan@hci.utah.edu
Washington University – School of Medicine 660 S Euclid Ave.
St. Louis, MO 63110
USA
Contact Info: Megan Copsey 314-747-3575 mcopsey@wustl.edu

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