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NCT00078585 · ClinicalTrials.gov registry record · Phase 2
PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
A Phase 2 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT00078585 is a Phase 2 study that has completed, run by Bavarian Nordic. The registered enrollment target is 120 participants.
The verdict
NCT00078585, a Phase 2 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer. This multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (AIPC). All patients will be required to sign an informed consent prior to the performance of any on-study procedures. Patients will be screened for eligibility within 14 days prior to vaccine administration. Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment. The ratio of active treatment to empty vector control (placebo) is 2:1.
Interventions
- BIOLOGICAL PROSTVAC®-VF/TRICOM™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2003-11 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078585
The ClinicalTrials.gov registry entry for NCT00078585 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bavarian Nordic, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PROSTVAC®-VF/TRICOM™ is the first listed.
NCT00078585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00078585 about?
NCT00078585 is a clinical study titled "PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy". PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will hel...
What is the current status of trial NCT00078585?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2003-11. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00078585?
The interventions under investigation include: PROSTVAC®-VF/TRICOM™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT00078585?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
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