Oncotelic Inc.
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.
OT-01-P201 is designed as a randomized, open-label, active controlled, multicenter Phase 2B/Phase 3 study designed to compare the efficacy and safety of OT-101 in combination with modified FOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to modified FOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer. The primary endpoint of the study is overall survival and key secondary endpoints are progression-free survival and objective response rate.
Inclusion Criteria: 1. A diagnosis of advanced and unresectable or metastatic pancreatic adenocarcinoma confirmed by: 1. Histopathology from primary tumor in pancreas, OR 2. 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. 2. Measurable disease per RECIST v.1.1 3. Male or non-pregnant, non-lactating female, ≥18 years or age 1. If a female patient is of child-bearing potential, as evidenced by menstrual periods, she must have a negative serum…
OT-101: antisense oligodeoxynucleotide complementary to the messenger ribonucleic acid (mRNA) of the human TGF-β2 gene
Folinic acid, 5-FU, Irinotecan, Oxaliplatin
Arctuva estimate
Verify or correct the compensation shown for this listing.