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
Oncotelic Inc.
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugOT-101
OT-101: antisense oligodeoxynucleotide complementary to the messenger ribonucleic acid (mRNA) of the human TGF-β2 gene
- DrugmFOLFIRINOX
Folinic acid, 5-FU, Irinotecan, Oxaliplatin
Locations (2)
- Karmanos Cancer CenterDetroit, Michigan
- Baylor College of MedicineHouston, Texas