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A Study of OT-101 with mFOLFIRINOX for Advanced Pancreatic Cancer

This study is testing a new drug, OT-101, in combination with a standard chemotherapy called mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) for people with advanced pancreatic cancer that cannot be removed by surgery or has spread. Researchers want to see if adding OT-101 to mFOLFIRINOX is safer and more effective than mFOLFIRINOX alone. The main goal is to see how long people live (Overall Survival) over 2.5 years. You may be able to join if you are 18 or older and have a confirmed diagnosis of advanced pancreatic adenocarcinoma. The study is currently recruiting about 455 participants, but its overall status is unclear.

Study design
This is a randomized, open-label study comparing two treatment groups. It is a Phase 2B/Phase 3 study and plans to enroll 455 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Overall survival will be measured at 2.5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06079346

A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Oncotelic Inc.
~455 participants
Updated 2024-08-13 on ClinicalTrials.gov
What's tested:OT-101mFOLFIRINOX

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over 2.5 years

Conditions

Pancreatic Ductal Adenocarcinoma

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Pancreatic Ductal Adenocarcinoma

NCT06079346

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor College of Medicine

    Houston, Texasno site contact published

    Recruiting

  • Karmanos Cancer Center

    Detroit, Michiganno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Cynthia Lee, PhD
[email protected]
(650) 635-7024
Email the study team

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Eligibility criteria

Inclusion

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
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)
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 8. Patient must have a life expectancy of ≥3 months in the opinion of the Investigator

What this trial measures

  • Overall Survival (OS)2.5 years

    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)