Metastatic Adenocarcinoma of the Pancreas MedDRA version: 21.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
Product Name: CPI-613 (devimistat)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: devimistat
Current Sponsor code: CPI-613
Other descriptive name: 6,8-BIS(BENZYLTHIO)O
Sponsors
Rafael Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 5.1.1 Histologically or cytologically confirmed metastatic Stage IV adenocarcinoma of the pancreas with relationship with to the primary tumor only. 5.1.2 No prior treatments for stage IV pancreatic adenocarcinoma (prior adjuvant or neoadjuvant treatment is allowed provided completed > 6 months prior to disease recurrence) 5.1.3 Eastern Cooperative Oncology Group (ECOG) performance status 0 – 1 5.1.4 Male and female patients 18 – 75 years of age 5.1.5 Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) 5.1.6 Expected survival >3 months 5.1.7 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 and, at the end of systemic exposure, and at 30 days after the systemic exposure 5.1.8 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 5.1.9 At least 2 weeks must have elapsed from any prior surgery with resolution of any sequela for randomization 5.1.10 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 =65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 5.2.1 Endocrine or acinar pancreatic carcinoma 5.2.2 Known cerebral metastases, central nervous system (CNS), or epidural tumor 5.2.3 Prior treatment with any chemotherapy for metastatic adenocarcinoma of the pancreas 5.2.4 Completion of a gemcitabine-based adjuvant chemotherapy regimen within less than 6 months at the time of screening. 5.2.5 Receipt of neoadjuvant or adjuvant FOLFIRINOX therapy if 480 milliseconds (ms) (CTCAE grade 1) using Fredericia’s QT correction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To evaluate Progression-Free Survival (PFS) of CPI-613® (devimistat) plus mFFX versus FFX • To determine efficacy of devimistat plus modified FOLFIRINOX (mFFX) compared to standard care FOLFIRINOX (FFX) in terms of Objective Response Rate (ORR). ORR is defined as Complete Response (CR) plus Partial Response (PR). • To evaluate Duration of Response (DOR) • Safety Analysis: The assessment of safety will be based mainly on the frequency of adverse events based on the Common Terminology Criteria for Adverse Events (CTCAE version 4) grade. Adverse events will be coded according to MedDRA. The safety outcomes will include the occurrence of at least one serious adverse event, of at least onegrade 3/4 adverse event, and of at least one adverse event requiring the discontinuation of study treatment. QTc intervals will be also evaluated as part of safety analysis. • To assess PK of devimistat. ;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: Date of randomization to the date of death from any cause;Main Objective: To evaluate Overall Survival (OS) of CPI-613® (devimistat) plus mFFX versus FFX. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Progression-Free Survival (PFS) 2. Overall Response Rate (ORR) 3. Duration of Response (DOR) 4. Safety: AEs, SAEs, QTc. 5. Pharmacokinetics 6. Patient-Reported Outcomes (PRO);Timepoint(s) of evaluation of this end point: 1. Date of randomization to the date of progressive disease or death from any cause 2. Patient's best response within the first 12 cycles 3. Date of initial documented response (CR or PR) to the first documented date of disease progression or death 4. Throughout the study 5. Day 1&3 of cycles 1&2, day 3 of subsequent cycles 6. Baseline and day 1 of every even numbered cycle | — |
Countries
Belgium, France, Germany, Israel, Italy, Korea, Republic of, Spain, United States
Contacts
Public ContactClinical Trials Information
Rafael Pharmaceuticals, Inc
Outcome results
None listed