Actively Recruiting
A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
Led by Oncotelic Inc. · Updated on 2024-08-13
455
Participants Needed
2
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of advanced, unresectable, or metastatic pancreatic adenocarcinoma confirmed by biopsy
- Measurable disease according to RECIST v.1.1 criteria
- Male or non-pregnant, non-lactating female aged 18 years or older
- Negative pregnancy test for females of childbearing potential before starting treatment
- Agreement to use effective contraception during the study and for 6 to 9 months after treatment
- Signed informed consent form
- ECOG Performance Status score of 0 or 1
- Willingness and ability to follow study procedures
- Adequate organ function based on blood tests within 28 days prior to randomization
- Life expectancy of at least 3 months as judged by the investigator
You will not qualify if you...
- Diagnosis of pancreatic tumors other than adenocarcinoma, such as islet neoplasm or acinar cell carcinoma
- Decline in ECOG Performance Status within 72 hours before randomization
- Use of Coumadin without willingness to switch to other specified anticoagulants
- History of prior malignancies unless disease-free for at least 3 years or controlled per investigator
- Serious medical conditions or psychiatric illness making participation inappropriate
- Abnormal ECG with prolonged QT interval or certain pacemaker conditions
- Uncontrolled serious infections requiring intravenous antibiotics
- Known HIV infection or active viral hepatitis A, B, or C
- Recent significant bleeding within 2 weeks prior to randomization
- Pregnancy or breastfeeding
- Recent major heart events or unstable heart conditions
- Significant ascites requiring frequent drainage
- Recent major surgery within 28 days before randomization
- Prior treatment with immune checkpoint inhibitors
- Peripheral neuropathy greater than grade 1
- Known deficiency of the enzyme dihydropyrimidine dehydrogenase
- History or risk of autoimmune diseases except certain mild conditions
- Use of certain medications including investigational agents, some anticoagulants, NSAIDs, and high-dose corticosteroids
- Known allergy to OT-101 or similar compounds
- Inability or unwillingness to comply with study visits and procedures
- Contraindications to components of the mFOLFIRINOX regimen
- Participation in another investigational trial within 30 days
- Significant psychiatric disorders or legal incapacity
- Primary immunodeficiency
- Active central nervous system metastases unless stable and approved by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Actively Recruiting
2
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Cynthia Lee, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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