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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Oncotelic Inc.
Study ID
NCT06079346
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OT-101 — DRUG
    OT-101: antisense oligodeoxynucleotide complementary to the messenger ribonucleic acid (mRNA) of the human TGF-β2 gene
  • mFOLFIRINOX — DRUG
    Folinic acid, 5-FU, Irinotecan, Oxaliplatin

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
May 2024
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
455 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 2.5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Karmanos Cancer CenterDetroitMichigan48201
Anthony Shields, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Shalini Makawita, MD

Find similar trials in Detroit, MI

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Karmanos Cancer Center· Detroit, MIBaylor College of Medicine· Houston, TX

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