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NCT00613509 · ClinicalTrials.gov registry record · Phase 2
Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00613509 is a Phase 2 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 23 participants.
The verdict
NCT00613509, a Phase 2 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
Primary objective: To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment. Secondary objectives: Safety: To describe the safety profile in both treatment groups. Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.
Interventions
- BIOLOGICAL ALVAC(2) Melanoma multi-antigen therapeutic vaccine
- BIOLOGICAL Intron A, Interferon alpha -2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00613509
The ClinicalTrials.gov registry entry for NCT00613509 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ALVAC(2) Melanoma multi-antigen therapeutic vaccine is the first listed.
NCT00613509 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00613509 about?
NCT00613509 is a clinical study titled "Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma". Primary objective: To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment. Secondary objectives: Safety: To describe the safety profile in both treatment groups. Efficacy: To determine the object...
What is the current status of trial NCT00613509?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2008-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00613509?
The interventions under investigation include: ALVAC(2) Melanoma multi-antigen therapeutic vaccine (BIOLOGICAL), Intron A, Interferon alpha -2b (BIOLOGICAL).
Who is sponsoring clinical trial NCT00613509?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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