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NCT02581215 · ClinicalTrials.gov registry record · Phase 2
Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer
A Phase 2 study of Pancreatic Cancer, sponsored by Walid Shaib, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 8
- Study locations
NCT02581215: Completed Phase 2 study of Pancreatic Cancer, sponsored by Walid Shaib, MD.
NCT02581215 is a Phase 2 study of Pancreatic Cancer that has completed, run by Walid Shaib, MD. The registered enrollment target is 84 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (79% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581215, a Phase 2 study of Pancreatic Cancer, has completed, sponsored by Walid Shaib, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both arms will continue treatment until disease progression or unacceptable toxicity.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time of registration until disease progr
Conditions Studied
Interventions
- OTHER Placebo
- DRUG mFOLFIRINOX
- DRUG Ramucirumab
Study Locations (8)
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
- Community Healthcare System - Munster
Pennsylvania
- Gettysburg Cancer Center - Gettysburg
- Thomas Jefferson University Kimmel Cancer Center - Philadelphia
Arizona
- Mayo Clinic-Arizona - Scottsdale
Georgia
- Emory University: Winship Cancer Institute - Atlanta
Kentucky
- University of Louisville, James Graham Brown Cancer Center - Louisville
Nebraska
- Nebraska Methodist Hospital - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2016-09-11 |
| Est. Completion | 2022-01-27 |
| Phase | Phase 2 |
What the finished NCT02581215 record still lists
NCT02581215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02581215 lists 8 locations in 6 states (Indiana, Pennsylvania, Arizona).
Frequently Asked Questions
What is clinical trial NCT02581215 about?
NCT02581215 is a clinical study titled "Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer". This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both arms will continue treatme...
What is the current status of trial NCT02581215?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2016-09-11. Estimated completion is 2022-01-27.
What conditions does trial NCT02581215 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT02581215?
The interventions under investigation include: Placebo (OTHER), mFOLFIRINOX (DRUG), Ramucirumab (DRUG).
Who is sponsoring clinical trial NCT02581215?
This trial is sponsored by Walid Shaib, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02581215 being conducted?
This trial has 8 study locations across Arizona, Georgia, Indiana, Kentucky, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02581215's enrollment target sits among peer trials
84 117th of 278 higher than 160 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer 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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