A Multicenter, Randomized, Double-blind, Parallel-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum-resistant and topotecan-and/or Liposomal Doxorubicin-resistant Advanced Ovarian Cancer
18 Years
N/A
Female
Neoplasms, Cancer of the Ovary
Trial Information
A Multicenter, Randomized, Double-blind, Parallel-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum-resistant and topotecan-and/or Liposomal Doxorubicin-resistant Advanced Ovarian Cancer
The study included:
- A screening period for 21 days
- Randomization at baseline (Treatment was initiated with 5 days of randomization)
- A treatment period with 14-day study treatment cycles until a study withdrawal
criterion was met
- A follow-up period up to 60 days after the end of treatment
Withdrawal criteria that led to treatment discontinuation were:
- The participant or their legally authorized representative requested to withdraw
- In the investigator's opinion, continuation of the study would be detrimental to the
participant's well being, due to reasons such as disease progression, unacceptable
toxicity, noncompliance, or logistical considerations.
- A specific request by the Sponsor
- Participant had intercurrent illness that prevented further administration of study
treatment
- Participant had more than 2 aflibercept dose reductions
- Participant had arterial thromboembolic events, including cerebrovascular accidents,
myocardial infarctions, transient ischemic attacks, new onset or worsening of
pre-existing angina
- Participant had radiographic evidence of intestinal obstruction (e.g., dilated loops of
bowel accompanied by air-fluid levels) or gastrointestinal perforation (e.g., presence
of extraluminal gas) requiring surgical intervention
- Participant was lost to follow-up
After discontinuing treatment, participants remained on the study until the last
post-treatment visit or until recovery of drug related toxicities, whichever was later.
Participants who met the following criteria were eligible for the study.
Inclusion Criteria:
- Histologically-confirmed ovarian epithelial (including fallopian tube and primary
peritoneal) adenocarcinoma.
- Prior treatment with at least 2 treatment regimens in the advanced disease treatment
setting
- 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
- Evidence of at least one unidimensional measurable tumor lesion by computed
tomography (CT) or magnetic resonance imaging (MRI) scan according to Response
Evaluation Criteria in Solid Tumors (RECIST) that has not been treated with surgery
or radiation therapy
Exclusion Criteria:
- Diagnosis of any second malignancy within the last 5 years, except for adequately
treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the
cervix uteri
- Prior treatment with a vascular endothelial growth factor (VEGF) or VEGF receptor
inhibitor
- More than 3 chemotherapy regimens in the advanced disease treatment setting
- Uncontrolled hypertension
The above information is not intended to contain all considerations relevant to potential
participation in a clinical trial.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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
Outcome Description:
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 Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later.
Outcome Time Frame:
From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)
Safety Issue:
No
Principal Investigator
ICD CSD
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
ARD6122
NCT ID:
NCT00327171
Start Date:
May 2006
Completion Date:
March 2010
Related Keywords:
- Neoplasms
- Cancer of the Ovary
- ovarian cancer
- angiogenesis
- angiogenesis inhibition
- VEGF-Trap fusion recombinant protein
- Cancer and other neoplasms
- Neoplasms
- Ovarian Neoplasms
Name | Location |
|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater, New Jersey 08807 |
