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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 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.

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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.

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

FieldValue
Enrollment Target 39 participants
Start Date 2016-04-27
Est. Completion 2021-06-09
Phase Phase 2

Sponsor

Shadia Jalal, MD

3 total trials

What the Registry Record Tells You About NCT02639065

The ClinicalTrials.gov registry entry for NCT02639065 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (92% lower). The listed sponsor is Shadia Jalal, MD, which has 3 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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