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NCT02639065 · ClinicalTrials.gov registry record · Phase 2
A Study of Durvalumab (MEDI4736) in Esophageal Cancer
A Phase 2 study of Esophageal Cancer, sponsored by Shadia Jalal, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 3
- Study locations
NCT02639065: Completed Phase 2 study of Esophageal Cancer, sponsored by Shadia Jalal, MD.
NCT02639065 is a Phase 2 study of Esophageal Cancer that has completed, run by Shadia Jalal, MD. The registered enrollment target is 39 participants, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02639065, a Phase 2 study of Esophageal Cancer, has completed, sponsored by Shadia Jalal, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. After six patients are treated with at least one dose of study drug, they will be observed for a minimum of 60 days. During the 60-day observation period, further accrual will be halted to evaluate "unacceptable toxicities warranting early closure of the trial" defined as: * Any definitive durvalumab-related death. A durvalumab-related death will be continuously monitored throughout the trial and the trial will be suspended for re-evaluation whenever such an event is confirmed. * Any unexpected and previously unreported grade 4 toxicities definitely related to durvalumab.
Primary Outcome
Relapse free survival is defined as time from the date of surgery until the criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the small
Conditions Studied
Interventions
- DRUG Durvalumab
Study Locations (3)
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Iowa
- Unversity of Iowa Hospital and Clinics - Iowa City
Michigan
- University of Michigan Health System - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2016-04-27 |
| Est. Completion | 2021-06-09 |
| Phase | Phase 2 |
What the finished NCT02639065 record still lists
NCT02639065 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 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Esophageal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Durvalumab is the first listed.
NCT02639065 reports a single indexed study location in Indiana, Iowa, Michigan.
Frequently Asked Questions
What is clinical trial NCT02639065 about?
NCT02639065 is a clinical study titled "A Study of Durvalumab (MEDI4736) in Esophageal Cancer". This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. After six patients are tre...
What is the current status of trial NCT02639065?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2016-04-27. Estimated completion is 2021-06-09.
What conditions does trial NCT02639065 study?
This clinical trial studies the following conditions: Esophageal Cancer.
What interventions are being tested in trial NCT02639065?
The interventions under investigation include: Durvalumab (DRUG).
Who is sponsoring clinical trial NCT02639065?
This trial is sponsored by Shadia Jalal, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02639065 being conducted?
This trial has 3 study locations across Indiana, Iowa, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02639065's enrollment target sits among peer trials
39 90th of 123 higher than 32 of 123 other Esophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal 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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