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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: Completed Phase 2 study, sponsored by Sanofi.
NCT00327171 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 218 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resona
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 |
What the finished NCT00327171 record still lists
NCT00327171 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% higher).
The record links to 0 conditions, and to 1 intervention - of which Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) is the first listed.
NCT00327171 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00327171's enrollment target sits among peer trials
218 284th of 2000 higher than 1,715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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