Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

218

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

March 31, 2010

Conditions
NeoplasmsCancer of the Ovary
Interventions
DRUG

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

"Aflibercept 4.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.~Aflibercept could be reduced by 1 dose level ( to 2.0 mg/kg) or 2 dose levels (to 1.0 mg/kg) in case of uncontrolled hypertension or urinary protein \>3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."

DRUG

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

"Aflibercept 2.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.~Aflibercept could be reduced by 1 dose level (to 1.0 mg/kg) or 2 dose levels (to 0.5 mg/kg) in case of uncontrolled hypertension or urinary protein \>3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."

Trial Locations (11)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, Macquarie Park

Sanofi-Aventis Administrative Office, Laval

Sanofi-Aventis Administrative Office, Paris

Sanofi-Aventis Administrative Office, Berlin

Sanofi-Aventis Administrative Office, Milan

Sanofi-Aventis Administrative Office, Gouda

Sanofi-Aventis Administrative Office, Porto Salvo

Sanofi-Aventis Administrative Office, Barcelona

Sanofi-Aventis Administrative Office, Bromma

Sanofi-Aventis Administrative Office, Geneva

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY