Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas

Completed · Phase 3

Conditions studied: Pancreatic Cancer Metastatic

In brief

A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years

Key facts

Study ID

NCT03504423

Run by

Cornerstone Pharmaceuticals

People needed

528

Starts

2018-11-09

Expected to finish

2022-01-02

Last updated by the study team

2023-01-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed metastatic Stage IV adenocarcinoma of the pancreas
• No prior treatments for stage IV pancreatic adenocarcinoma (prior adjuvant or neoadjuvant treatment is allowed provided completed > 6 months prior to disease recurrence)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
• Male and female patients 18 - 75 years of age
• Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
• Expected survival >3 months
• 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
• 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
• At least 2 weeks must have elapsed from any prior surgery with resolution of any sequela for randomization
• Laboratory values ≤2 weeks prior to randomization must be:
• Adequate hematologic values
• Platelet count ≥100,000 cells/mm3 or ≥100 bil/L;
• Absolute neutrophil count [ANC] ≥1,500 cells/mm3 or ≥1.5 bil/L;
• Hemoglobin ≥9 g/dL or ≥90 g/L)
• Adequate hepatic function
• Aspartate aminotransferase [AST/SGOT] ≤3x upper normal limit [UNL] (≤5x UNL if liver metastases present)
• Alanine aminotransferase [ALT/SGPT] ≤3x UNL (≤5x UNL if liver metastases present)
• Bilirubin (≤1.5x UNL); bilirubin ≤ 2.5 x ULN for subjects with Gilbert's syndrome
• Serum albumin > 3.0 g/dL
• Adequate renal function serum creatinine clearance CLcr > 30 mL/min). (Cocroft-Gault Formula should be used for CrCl calculation)
• Adequate coagulation function • International Normalized Ratio or INR must be <1.5 unless on therapeutic blood thinners)
• No evidence of active infection and no serious infection within the past 30 days.
• Mentally competent, ability to understand and willingness to sign the informed consent form.

You may not qualify if…

• Endocrine or acinar pancreatic carcinoma
• Known cerebral metastases, central nervous system (CNS), or epidural tumor
• Prior treatment with any chemotherapy for metastatic adenocarcinoma of the pancreas
• Completion of a gemcitabine-based adjuvant chemotherapy regimen within less than 6 months at the time of screening.
• Receipt of neoadjuvant or adjuvant FOLFIRINOX therapy if <6 months prior to disease recurrence
• Patients with hypersensitivity to devimistat, FFX treatment or any of their excipients
• Presence of clinically significant abdominal ascites
• 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
• Serious medical illness that would potentially increase patients' risk for toxicity
• Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
• 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
• Female patients of childbearing potential with a positive pregnancy test assessed by a serum pregnancy test at screening
• 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
• 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
• Male patients unwilling to abstain from donating sperm during treatment and for 6 months after completion of study treatment
• Life expectancy less than 3 months
• Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
• Unwilling or unable to follow protocol requirements
• 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
• Patients with a history of myocardial infarction that is <3 months prior to registration
• Evidence of active infection, or serious infection within the past 30 days.
• Patients with known HIV infection
• 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)
• 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
• 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

Where it is running

• The University of Arizona Cancer Center — Tucson, Arizona, United States
• City of Hope — Duarte, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Mayo Clinic Hospital — Jacksonville, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Northwestern Memorial Hospital - Arkes Family Pavilion — Chicago, Illinois, United States
• University of Chicago — Harvey, Illinois, United States
• The University of Kansas Cancer Center - Clinical Research Center - Fairway Office Park — Fairway, Kansas, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• University of Micihgan — Ann Arbor, Michigan, United States
• Karmanos cancer Center — Detroit, Michigan, United States
• Mayo Clinic Cancer Center (MCCC) — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Comprehensive Cancer centers of Nevada — Las Vegas, Nevada, United States
• Englewood Hospital and Medical Center — Englewood, New Jersey, United States
• Atlantic Health System — Morristown, New Jersey, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• New York University Langone Medical Center — New York, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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