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NCT00327171 · ClinicalTrials.gov registry record · Phase 2
Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 218
- Enrollment target
NCT00327171 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 218 participants.
The verdict
NCT00327171, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 218 participants
- Enrollment target
Study Summary
This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept. The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks with historical control in participants with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin. The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life. This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the IRC reviewed data is reported for this study.
Interventions
- DRUG Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2006-05 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00327171
The ClinicalTrials.gov registry entry for NCT00327171 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 218 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 1 intervention - of which Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) is the first listed.
NCT00327171 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00327171 about?
NCT00327171 is a clinical study titled "Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer". This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept. The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (I...
What is the current status of trial NCT00327171?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 218 participants. The study started on 2006-05. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00327171?
The interventions under investigation include: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) (DRUG).
Who is sponsoring clinical trial NCT00327171?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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