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NCT00300950 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer

A Phase 2 study of Pancreas Cancer, sponsored by GlobeImmune.

Completed
Registry status
Phase 2
Development phase
176
Enrollment target
20
Study locations

NCT00300950 is a Phase 2 study of Pancreas Cancer that has completed, run by GlobeImmune. The registered enrollment target is 176 participants, below the 904-participant average among 54 other Pancreas Cancer trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00300950, a Phase 2 study of Pancreas Cancer, has completed, sponsored by GlobeImmune.

COMPLETED
Registry status
Phase 2
Development phase
176 participants
Enrollment target
20
Study locations

Study Summary

The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.

Conditions Studied

Interventions

  • DRUG Gemcitabine
  • BIOLOGICAL GI-4000

Study Locations (20)

Texas

  • Texas Oncology, PA - Dallas
  • The Texas Cancer Center Dallas Southwest - Dallas
  • Baylor College of Medicine - Houston
  • South Texas Oncology & Hematology - San Antonio
  • Tyler Cancer Center - Tyler

California

  • Tower Cancer Research Foundation - Beverly Hills
  • University of California San Diego - La Jolla
  • UCLA Medical Center - Los Angeles

Tamil Nadu

  • PSG Hospitals - Peelamedu, Coimbatore
  • Sri Ramchandra Medical College & Research Institute - Ponur, Chennai

Alabama

  • University of Alabama at Birmingham - Birmingham

District of Columbia

  • Georgetown University Medical Center / Lombardi Cancer Center - Washington D.C.

Illinois

  • Rush University Medical School - Chicago

Minnesota

  • Minnesota Oncology Hematology, PA - Minneapolis

Missouri

  • Washington University - St Louis

Trial Details

FieldValue
Enrollment Target 176 participants
Start Date 2006-01
Est. Completion 2015-02
Phase Phase 2

Sponsor

GlobeImmune

4 total trials

What the Registry Record Tells You About NCT00300950

The ClinicalTrials.gov registry entry for NCT00300950 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 904-participant average among 54 other Pancreas Cancer trials with a reported enrollment target (81% lower). The listed sponsor is GlobeImmune, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pancreas Cancer appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.

NCT00300950 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Texas, California, Tamil Nadu.

Frequently Asked Questions

What is clinical trial NCT00300950 about?

NCT00300950 is a clinical study titled "Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer". The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.

What is the current status of trial NCT00300950?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2006-01. Estimated completion is 2015-02.

What conditions does trial NCT00300950 study?

This clinical trial studies the following conditions: Pancreas Cancer.

What interventions are being tested in trial NCT00300950?

The interventions under investigation include: Gemcitabine (DRUG), GI-4000 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00300950?

This trial is sponsored by GlobeImmune, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00300950 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Illinois, Minnesota. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.