A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.
• A diagnosis of advanced and unresectable or metastatic pancreatic adenocarcinoma confirmed by:
∙ Histopathology from primary tumor in pancreas, OR
‣ Histopathology from a non-pancreatic lesion in the presence of a mass in the pancreas consistent with pancreatic adenocarcinoma or a medically documented history of pancreatic adenocarcinoma.
• Measurable disease per RECIST v.1.1
• Male or non-pregnant, non-lactating female, ≥18 years or age
∙ If a female patient is of child-bearing potential, as evidenced by menstrual periods, she must have a negative serum pregnancy test (beta-human chorionic gonadotropin \[β- hCG\]) documented prior to the first administration of stud drugs
‣ Female patients of childbearing age and women \< 12 months since the onset of menopause must agree to use acceptable contraceptive methods for the duration of the study and 9 months following the last injection of OT-101.
‣ Male patients must use effective contraception for a duration of 6 months after the final dose, as per the prescribing information for oxaliplatin.
• Provide signed written informed consent
• Eastern Cooperative Group (ECOG) Performance Status (PS) score of 0-1
• Willingness and ability to comply with study requirements
• Patient has adequate organ function by the following laboratory assessments at baseline(obtained ≤28 days prior to Randomization):
• Hematologic
⁃ Platelets ≥100×109/L
⁃ Hemoglobin ≥9.0 g/dL
⁃ Absolute Neutrophil Count (ANC) ≥1.5×109/L
⁃ Patient has acceptable coagulation values obtained ≤28 days prior to Randomization as demonstrated by prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) ≤1.5× upper limit of normal (ULN) (if on Coumadin, patient must be changed to LMWH or on Factor II or Xa anticoagulant with a t½ of less than 24 hours
• Hepatic
⁃ Aspartate transaminase (AST)/alanine transaminase (ALT) ≤3×ULN (if liver metastases are present, ≤5×ULN)
⁃ Alkaline phosphatase ≤2.0×ULN (if liver metastases are present, ≤5×ULN)
⁃ Total bilirubin ≤2.0×ULN (in patients with Gilbert's Syndrome total bilirubin \< or = 2.5xULN)
• Renal
⁃ Calculated creatinine clearance ≥50 mL/min. Actual body weight should be used for calculating creatinine clearance (e.g., using the Modification of Diet in Renal Disease \[MDRD\] formula. For patients with a body mass index (BMI) \>30 kg/m2, lean body weight should be used instead
• Patient must have a life expectancy of ≥3 months in the opinion of the Investigator