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NCT02268825 · ClinicalTrials.gov registry record · Phase 1
Phase I Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers
A Phase 1 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT02268825: Clinical Trial Phase 1 study, sponsored by University of Utah.
NCT02268825 is a Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02268825, a Phase 1 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with mFOLFOX6 followed by a safety expansion open label, nonrandomized trial with MK-3475 at MTD in combination with mFOLFOX6 and supplemental celecoxib in 4 cohorts of advanced/metastatic GI malignancies (pancreatic, gastro esophageal, colorectal/appendiceal adenocarcinoma and biliary carcinoma) to assess response rate, clinical benefit rate, progression free survival and overall survival. The safety expansion cohort will assess the effect of the addition of celecoxib to patients that do not respond to combination MK-3475/mFOLFOX treatment.
Primary Outcome
Routine safety and tolerability will be evaluated from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. More frequent safety evaluations may be performed if clinically indicated or at the discretion of the investigator.
Interventions
- DRUG MK-3475
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2015-01-23 |
| Est. Completion | 2017-06-26 |
| Phase | Phase 1 |
Why NCT02268825 stopped before completion
NCT02268825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which MK-3475 is the first listed.
NCT02268825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02268825 about?
NCT02268825 is a clinical study titled "Phase I Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers". This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with mFOLFOX6 followed by a safety expansion open label, nonrandomized trial with MK-3475 at MTD in combination with mFOLFOX6 and supplemental celecoxib in 4 cohorts of advanced/metastatic GI malignancies (pancreatic, ga...
What is the current status of trial NCT02268825?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2015-01-23. Estimated completion is 2017-06-26.
What interventions are being tested in trial NCT02268825?
The interventions under investigation include: MK-3475 (DRUG).
Who is sponsoring clinical trial NCT02268825?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02268825's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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