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NCT06079346 · ClinicalTrials.gov registry record · Phase 2
A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
A Phase 2 study of Pancreatic Ductal Adenocarcinoma, sponsored by Oncotelic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 455
- Enrollment target
- 2
- Study locations
NCT06079346: Recruiting Phase 2 study of Pancreatic Ductal Adenocarcinoma, sponsored by Oncotelic.
NCT06079346 is a Phase 2 study of Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by Oncotelic. The registered enrollment target is 455 participants, below the 595-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (24% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06079346, a Phase 2 study of Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by Oncotelic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 455 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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)
Conditions Studied
Interventions
- DRUG mFOLFIRINOX
- DRUG OT-101
Study Locations (2)
Michigan
- Karmanos Cancer Center - Detroit
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
What NCT06079346 shows while recruiting
NCT06079346 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, below the 595-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which mFOLFIRINOX is the first listed.
NCT06079346 reports a single indexed study location in Michigan, Texas.
Frequently Asked Questions
What is clinical trial NCT06079346 about?
NCT06079346 is a clinical study titled "A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer". 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.
What is the current status of trial NCT06079346?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 455 participants. The study started on 2024-05-01. Estimated completion is 2027-06-01.
What conditions does trial NCT06079346 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT06079346?
The interventions under investigation include: mFOLFIRINOX (DRUG), OT-101 (DRUG).
Who is sponsoring clinical trial NCT06079346?
This trial is sponsored by Oncotelic, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06079346 being conducted?
This trial has 2 study locations across Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pancreatic Ductal Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06079346's enrollment target sits among peer trials
455 15th of 84 higher than 70 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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