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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
Karmanos Cancer Center
RECRUITING
Detroit
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Cynthia Lee, PhD
clee@oncotelic.com
(650) 635-7024
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 455
Treatments
Active_comparator: OT-101 + mFOLFIRINOX
OT-101 IV dosed on Days 4-7 plus mFOLFIRINOX (dl-LV 400 mg/m2, irinotecan 180 mg/m2 and oxaliplatin 85 mg/m2 followed by a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycle
Placebo_comparator: mFOLFIRINOX Only
mFOLFIRINOX (dl-LV 400 mg/m2, irinotecan 180 mg/m2 and oxaliplatin 85 mg/m2 followed by a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycle
Related Therapeutic Areas
Sponsors
Leads: Oncotelic Inc.

This content was sourced from clinicaltrials.gov