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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 is a Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 39 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02268825
The ClinicalTrials.gov registry entry for NCT02268825 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MK-3475 is the first listed.
NCT02268825 reports 0 study locations.
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.
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