Trial Period
11/09/2018 - 03/2022
Conditions
Metastatic Pancreatic Cancer Pancreatic Cancer
(33) 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
  • 33 Locations
  • Recruiting
Trial Period
11/09/2018 - 03/2022
Conditions
Metastatic Pancreatic Cancer Pancreatic Cancer
(33) 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.

More Info

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 Stage IV 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 highly effective 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 after last study dose and
    must have a negative serum or urine pregnancy test within 1 week prior to treatment
    initiation, at monthly interval (day 1 of every even numbered cycle), at the end of systemic
    exposure, and at 30 days after the systemic exposure
  8. Males with female partners (of childbearing potential) and female partners (of child bearing
    potential) with male partners must agree to use double barrier contraceptive measure (a
    combination of male condom with either cap, diaphragm or sponge with spermicide) in
    addition to 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] (≤5x
        UNL if liver metastases present)
      2. Alanine aminotransferase [ALT/SGPT] ≤3x UNL (≤5x UNL if liver metastases
        present)
      3. Bilirubin (≤1.5x UNL); bilirubin ≤ 2.5 x ULN for subjects with Gilbert’s
        syndrome
      4. Serum albumin > 3.0 g/dL
    3. Adequate renal function:
      1. serum creatinine clearance CLcr > 30 mL/min). (Cocroft-Gault Formula
        should be used for CrCl calculation)
    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 if <6 months prior to disease recurrence
  6. Patients with hypersensitivity to devimistat, FFX treatment or any of their excipients
  7. Presence of clinically significant abdominal ascites
  8. 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 devimistat treatment
  9. Serious medical illness that would potentially increase patients’ risk for toxicity
  10. Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
  11. Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of study treatment
  12. Female patients of childbearing potential with a positive pregnancy test assessed by a
    serum pregnancy test at screening
  13. Female patients of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for 6 months after the last dose of study treatment
  14. Male patients with a pregnant partner who are unwilling to practice abstinence or use a
    condom during treatment and for 6 months after completion of study treatment
  15. Male patients unwilling to abstain from donating sperm during treatment and for 6 months after completion of study treatment
  16. Life expectancy less than 3 months
  17. Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
  18. Unwilling or unable to follow protocol requirements
  19. 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
  20. Patients with a history of myocardial infarction that is <3 months prior to registration
  21. Evidence of active infection, or serious infection within the past 30 days.
  22. Patients with known HIV infection
  23. Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of devimistat treatment (steroids given for supportive care or in response to allergic reactions are allowed at any time)
  24. Requirement for immediate palliative surgery, radiation or chemotherapy of any kind. Stenting for bile duct obstruction and need for pain medications are allowed provided all other inclusion criteria are met
  25. 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
  26. Unwilling or unable to avoid the concomitant use of strong CYP3A4 inducers or inhibitors
    during treatment with irinotecan
  27. 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)
  28. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of long QT syndrome)
  29. The use of concomitant medications that prolong the QT/QTc intervals
  30. Contraindications to any of the FFX treatment as follows:
    1. Folinic Acid
      1. Calcium Folinate is contraindicated in patients who have previously shown hypersensitivity to folinate or any of the excipients.
      2. Calcium Folinate Injection is contraindicated in the treatment of pernicious anemia or other megaloblastic anemias where vitamin B12 is deficient. Its use can lead to an apparent response of the hematopoietic system, but neurological damage may occur or progress if already present.
      3. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take calcium folinate tablets.
    2. 5FU/ Fluorouracil
      1. Fluorouracil is contraindicated in patients who have any known hypersensitivity to fluorouracil, are seriously debilitated or are suffering from bone marrow depression after radiotherapy or treatment with other antineoplastic agents, or who are suffering from a potentially serious infection.
      2. Fluorouracil is strictly contraindicated in pregnant or breast-feeding women.
      3. Flourouracil should not be used in the management of non-malignant disease.
      4. Fluorouracil must not be taken or used concomitantly with brivudin, sorivudine and analogues. Brivudin, sorivudine and analogues are potent inhibitors of the enzyme dihydropyrimidine dehydrogenase (DPD) which degrades fluorouracil
      5. In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity
    3. Oxaliplatin
      1. Oxaliplatin is contraindicated in patients who have a known history
        of hypersensitivity to oxaliplatin or to any of the excipients
      2. are breast-feeding
      3. have myelosuppression prior to starting first course, as evidenced by
        baseline neutrophils <2x109/l and/or platelet count of <100x109l
      4. have a peripheral sensitive neuropathy with functional impairment
        prior to first course
      5. have a severely impaired renal function (creatinine clearance less
        than 30 ml /min)
    4. Irinotecan
      1. Chronic inflammatory bowel disease and/or bowel obstruction
      2. History of severe hypersensitivity reactions to Irinotecan hydrochloride trihydrate or to any of the excipients
      3. Bilirubin > 3 times the ULN
      4. Severe bone marrow failure.
      5. WHO performance status > 2.
      6. Concomitant use with St John’s wort

Trial Site Locations (33)

View All Locations
Wake Forest Baptist Medical Center 1475 Nw 12th Ave
Winston Salem, NC 27157
USA
Contact Info: Caio Max Rocha-Lima
University of Pittsburgh – Hillman Cancer Center 5115 Centre Avenue
Pittsburgh, PA 15232-1301
USA
Contact Info: Wendy Lane-Scott (412) 864-7688 lanewg@upmc.edu
Georgetown University Medical Center 3800 Reservoir Rd NW
Washington, DC 20007-2113
USA
Contact Info: Nicole Villa (202) 687-7606 nv209@georgetown.edu
Morristown Medical Center 100 Madison Ave
Morristown, NJ 7960
USA
Contact Info: Jannette Vetere jannette.vetere@atlantichealth.org
Ingalls Memorial Hospital One Ingalls Drive
W740
Harvey, IL 60426
USA
Contact Info: Stacy Chandler (708) 915-6853 schandler@ingalls.org
New York University Langone Medical Center 160 East 34th Street
New York, NY 10016-4744
USA
Contact Info: Paul Oberstein
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center-Henry-Joyce Cancer Clinic 1301 Medical Center Dr
Ste 1710
Nashville, TN 37232-0028
USA
Contact Info: Dana Cardin
Huntsman Cancer Institute 2000 Circle of Hope Drive
Room 2450
Salt Lake City, UT 84112-5550
USA
Contact Info: Ignacio Garrido-Laguna
Levine Cancer Institute 1021 Morehead Medical Dr
Charlotte, NC 28204-2990
USA
Contact Info: Mohamed Salem
Mayo Clinic Cancer Center (MCCC) – Rochester 200 First Street SW
Rochester, MN 55905
USA
Contact Info: Lucas Hamann hamann.lucas@mayo.edu
Blue Ridge Cancer Care – Roanoke 2013 South Jefferson Street SW
2nd Floor
Roanoke, VA 24014
USA
Contact Info: Mark Kochenderfer
Washington University School of Medicine in St. Louis 660 S Euclid Avenue
St. Louis, MO 63110-1010
USA
Contact Info: Megan MacDougall (314) 273-2637 macdougallm@wustl.ed
University of New Mexico Cancer Center 1201 Camino de Salud NE
Albuquerque, NM 87102-4517
USA
Contact Info: Heloisa Soares
University of Michigan Comprehensive Cancer Center 1500 E. Medical Center Drive
Ann Arbor, MI 48109
USA
Contact Info: Vaibhav Sahai
Karmanos Cancer Institute 4100 John R Street
Detroit, MI 48201
USA
Contact Info: Taylor Brewer (313) 576-8526 brewert@karmanos.org
Roswell Park Cancer Institute Elm and Carlton Street
Buffalo, NY 14263
USA
Contact Info: Christos Fountzilas
Smilow Cancer Hospital at Yale-New Haven 20 York Street
New Haven, CT 06510
USA
Contact Info: Jill Lacy
Oregon Health & Science University 3303 SW Bond Avenue
Portland, OR 97239-4501
USA
Contact Info: Charles Lopez
Stony Brook University Hospital 101 Nicholls Rd
Stony Brook, NY 11794
USA
Contact Info: Giuseppina Caravella (631) 216-2967 giuseppina.caravella@stonybrookmedicine.edu
Seattle Cancer Care Alliance 825 Eastlake Ave East
G5-920
Seattle, WA 98109
USA
Contact Info: T. Samantha Elliott (206) 606-6387 tellio@seattlecca.org
Mount Sinai Medical Center 4306 Alton Road
Miami Beach, FL 33140-2840
USA
Contact Info: Tresalynn Morris Tresalynn.morris@msmc.com
VCU Massey Cancer Center 401 College Street
No. 980037
Richmond, VA 23298
USA
Contact Info: Steven Grossman
Pacific Hematology Oncology Associates 2100 Webster Street
Suite 225
San Francisco, CA 94115
USA
Contact Info: Kaylee Tran (415) 600-5766 trank11@sutterhealth.org
Hillel Yaffe Medical Center P.O.Box 169
Medical Ctr, Hillel Yaffe
Hadera, HA 38101
Israel
Contact Info: Lucy Marhasin lucym@hy.health.gov.il
University Hospitals Seidman Cancer Center 11100 Euclid Ave
Cleveland, OH 44106-1716
USA
Contact Info: Erin Anderson (216) 286-3839 erin.anderson@uhhospitals.org
The Chaim Sheba Medical Center Oncology Institute
Ramat Gan,
Israel
Assaf Harofeh Medical Center Oncology Department
Be'er Ya'akov,
Israel
Contact Info: Aya Batat 972-8-9542097 ayab@asaf.health.gov.il
Kyungpook National University Chilgok Hospital 807 Hoguk-ro, Gugu-dong, Buk-gu
Daegu,
South Korea
Institut de Cancérologie de Lorraine 6 Avenue de Bourgogne
Vandœuvre-Lès-Nancy,
France
CHRU Brest – Hôpital Morvan 2 Avenue Foch
Brest, 29200
France
Contact Info: Abdesslam Chajara abdesslam.chajara@chu-brest.fr
University of Kansas Medical Center (KUMC)
Kansas City, KS 66160
Contact Info: Christine Mackay

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