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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
NCT00300950 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2006-01 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00300950
The ClinicalTrials.gov registry entry for NCT00300950 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlobeImmune, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00300950 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Texas, California, Tamil Nadu. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00300950?
The interventions under investigation include: Gemcitabine (DRUG), GI-4000 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00300950?
This trial is sponsored by GlobeImmune, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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