A Multicenter, Open-label, Single-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum- and Erlotinib-resistant Locally Advanced or Metastatic Non-small-cell Lung Adenocarcinoma
The study included :
- A screening phase up to 21 days followed by registration
- Treatment initiation within 5 working days of registration
- A treatment phase with 14-day study treatment cycles until a study withdrawal criterion
was met or up to the clinical database cut-off date (18 July 2008)
- A follow-up phase - up to 60 days after 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
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC).
OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions). Assessments were made by the IRC, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response.
up to 2.5 years from initial treatment
United States: Food and Drug Administration
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