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NCT00574275 · ClinicalTrials.gov registry record · Phase 3
Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 546
- Enrollment target
NCT00574275 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 546 participants.
The verdict
NCT00574275, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 546 participants
- Enrollment target
Study Summary
The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine. The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine). The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.
Interventions
- DRUG Placebo
- DRUG Gemcitabine
- DRUG Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00574275
The ClinicalTrials.gov registry entry for NCT00574275 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 546 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00574275 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00574275 about?
NCT00574275 is a clinical study titled "Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer". The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine. The secondary objectives were to evaluate progression free surviva...
What is the current status of trial NCT00574275?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 546 participants. The study started on 2007-12. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00574275?
The interventions under investigation include: Placebo (DRUG), Gemcitabine (DRUG), Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) (DRUG).
Who is sponsoring clinical trial NCT00574275?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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