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

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT00327171
Phase
PHASE2
Status
Completed

Conditions

  • Cancer of the Ovary
  • Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) — DRUG
    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 Participants requiring more than 2 dose level reductions would be withdrawn from study treatment.
  • Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) — DRUG
    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 Participants requiring more than 2 dose level reductions would be withdrawn from study treatment.

Study Details

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.

Key Dates

Start date
May 31, 2006
Status verified
May 2016
Primary completion
Apr 30, 2008
Completion
Mar 31, 2010

Study Design

Enrollment
218 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept 2.0 mg/kg
    Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept.
  • Experimental: Aflibercept 4.0 mg/kg
    Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept.

Primary Outcome Measure

Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort [ Time Frame: From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey08807-

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Sanofi-Aventis Administrative Office· Bridgewater, NJ

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