Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00396591 · ClinicalTrials.gov registry record · Phase 2
AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites
A Phase 2 study of Ovarian Neoplasms, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 3
- Study locations
NCT00396591: Completed Phase 2 study of Ovarian Neoplasms, sponsored by Sanofi.
NCT00396591 is a Phase 2 study of Ovarian Neoplasms that has completed, run by Sanofi. The registered enrollment target is 16 participants, below the 367-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00396591, a Phase 2 study of Ovarian Neoplasms, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites. The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.
Primary Outcome
RPR was defined as at least a two-fold increase in the time to repeat paracentesis (TRP) as compared to the average duration of the 2 intervals between the 3 most recent paracenteses prior to study registration (ie, the baseline interval of paracentesis). Percentage of participants with a repeat paracentesis response were the number of participants with RPR / number of total participants \* 100.
Conditions Studied
Interventions
- DRUG Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Study Locations (3)
Other
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Bromma
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
What the finished NCT00396591 record still lists
NCT00396591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 367-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Ovarian Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) is the first listed.
NCT00396591 reports a single indexed study location in Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00396591 about?
NCT00396591 is a clinical study titled "AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites". The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites. The secondary objectives were to further assess efficacy...
What is the current status of trial NCT00396591?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2006-10. Estimated completion is 2008-11.
What conditions does trial NCT00396591 study?
This clinical trial studies the following conditions: Ovarian Neoplasms.
What interventions are being tested in trial NCT00396591?
The interventions under investigation include: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) (DRUG).
Who is sponsoring clinical trial NCT00396591?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00396591 being conducted?
This trial has 3 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ovarian Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00396591's enrollment target sits among peer trials
16 39th of 38 the lowest of 38 other Ovarian Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Neoplasms 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
-
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
RECRUITING · Phase 2
-
Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Appendiceal, Small Bowel, Gastric, Cholangiocarcinoma, Breast, Ovarian, or Other Gynecologic Primary Cancer
ACTIVE NOT RECRUITING · Phase 2
-
A Trial of Vigil for Participants With Ovarian Cancer
ACTIVE NOT RECRUITING · Phase 2
-
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
ACTIVE NOT RECRUITING · Phase 2
-
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
COMPLETED · Phase 2
-
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia