AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites
A Multicenter, Open-label, Single-arm Study of the Efficacy and Safety of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
2 other identifiers
interventional
16
3 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2006
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 6, 2006
CompletedFirst Posted
Study publicly available on registry
November 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
January 10, 2013
CompletedJanuary 10, 2013
July 1, 2011
2.1 years
November 6, 2006
August 17, 2012
January 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Repeat Paracentesis Response (RPR)
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.
up to 2 years post-registration
Secondary Outcomes (6)
Time to Repeat Paracentesis (TRP)
up to 6 months from registration
60-day Frequency of Paracentesis (FOP)
up to 60 days post-registration
Progression-free Survival (PFS) Time
up to 6 months post-registration
Overall Survival (OS) Time
up to 6 months post-registration
Number of Participants With a Positive Anti-drug Antibody Response
up to 60 days after the last dose of treatment
- +1 more secondary outcomes
Study Arms (1)
Aflibercept
EXPERIMENTALParticipants with advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) treated with Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
Interventions
4.0 mg/kg administered intravenously (IV) once every 2 weeks
Eligibility Criteria
You may qualify if:
- Symptomatic malignant ascites resulting from advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) that required at least 3 previous therapeutic paracenteses at a frequency of 1 to 4 paracenteses per month for management.
- Platinum resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
- Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
You may not qualify if:
- Peritoneovenous or other type of shunt that was placed for the management of ascites
- Prior treatment with a VEGF or VEGF receptor inhibitor
- Uncontrolled hypertension
- The above information is not intended to contain all considerations relevant to participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (3)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Bromma, Sweden
Related Publications (1)
Colombo N, Mangili G, Mammoliti S, Kalling M, Tholander B, Sternas L, Buzenet G, Chamberlain D. A phase II study of aflibercept in patients with advanced epithelial ovarian cancer and symptomatic malignant ascites. Gynecol Oncol. 2012 Apr;125(1):42-7. doi: 10.1016/j.ygyno.2011.11.021. Epub 2011 Nov 21.
PMID: 22112608DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- sanofi-aventis
Study Officials
- STUDY DIRECTOR
ICD
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2006
First Posted
November 7, 2006
Study Start
October 1, 2006
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
January 10, 2013
Results First Posted
January 10, 2013
Record last verified: 2011-07