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.
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
Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (ie,lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
Patient has experienced a decrease in ECOG PS between Screening visit and within 72 hours prior to Randomization
Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with t½ of less than 24 hours
History of prior malignancy, except for adequately treated in situ cancer, basal cell, squamous cell skin cancer, or other cancers (eg, breast and prostate) for which the patient has been disease-free for at least 3 years. Patients with prior cancer that is adequately controlled per the judgement of the Investigator will not be excluded from the study
Parallel
OT-101
DrugOT-101: antisense oligodeoxynucleotide complementary to the messenger ribonucleic acid (mRNA) of the human TGF-β2 gene
mFOLFIRINOX
DrugFolinic acid, 5-FU, Irinotecan, Oxaliplatin
Overall Survival (OS)
To compare the efficacy of OT-101 in combination with mFOLFIRINOX versus mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer as measured by overall survival (OS)
Pharmacokinetic (PK) Parameter - Area Under the Curve (AUC)
To characterize the area under the curve (AUC) of OT-101 when it is combined with mFOLFIRINOX in patients with advanced and unresectable or metastatic pancreatic cancer. Area under the curve is a measure of how much a drug reaches a person's bloodstream in a given period of time after a dose is given.
Pharmacokinetic (PK) Parameter - Cmax
To characterize the Cmax of OT-101 when it is combined with mFOLFIRINOX in patients with advanced and unresectable or metastatic pancreatic cancer. Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.
Progression-Free Survival (PFS)
To assess the efficacy of OT-101 in combination with mFOLFIRINOX in patients with advanced and unresectable or metastatic pancreatic cancer as measured by Progression-free survival (PFS)
Objective Response Rate (ORR)
To assess the efficacy of OT-101 in combination with mFOLFIRINOX in patients with advanced and unresectable or metastatic pancreatic cancer as measured by Objective Response Rate (ORR)
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