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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pulmonary Diseases, Neoplasms, Lung

Thank you

Trial Information

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
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 non-small-cell lung adenocarcinoma that is locally advanced
or metastatic

- Prior treatment with at least 2 cancer drug regimens in the advanced disease setting

- Platinum- and erlotinib-resistant disease defined by relapse or progression during or
after treatment

- Measurable disease by RECIST criteria

- ECOG Performance status less than or equal to 2

- Resolution of any toxic effects of prior therapy

- Adequate organ and bone marrow function

- Female patients must be post-menopausal, surgically sterile or using effective
contraception

- Willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

- Diagnosis of squamous-cell lung cancer or any second malignancy within the last 5
years (except for adequately treated basal cell or squamous cell skin cancer or in
situ carcinoma of the cervix uteri)

- Prior treatment with a VEGF or VEGF receptor inhibitor with the exception of
bevacizumab (Avastin-TM)

- Anticipation of a need for major surgical procedure

- Treatment with chemotherapy, radiotherapy, surgery, blood products, or an
investigational agent within 3 weeks (6 weeks for nitrosoureas, mitomycin C,
immunotherapy, or cytokine therapy) of study enrollment

- Uncontrolled hypertension

- Any severe or acute medical or psychiatric problem within the past 6 months requiring
further investigation or that may cause undue risk for the patient's safety

- History of brain metastases, spinal cord compression, or carcinomatous meningitis, or
new evidence of brain or leptomeningeal disease

- Active infection or on antiretroviral therapy for HIV disease

- Pregnant or breast-feeding

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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC).

Outcome Description:

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.

Outcome Time Frame:

up to 2.5 years from initial treatment

Safety Issue:

No

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

ARD6123

NCT ID:

NCT00284141

Start Date:

January 2006

Completion Date:

July 2008

Related Keywords:

  • Pulmonary Diseases
  • Neoplasms, Lung
  • lung
  • cancer
  • non-small-cell lung cancer
  • metastatic
  • carcinoma
  • lung neoplasm
  • lung diseases
  • angiogenesis
  • anti-angiogenesis
  • anti-angiogenesis inhibitors
  • cancer and other neoplasms
  • respiratory tract
  • (lung and bronchial) diseases
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Lung Diseases
  • Respiration Disorders
  • Lung Neoplasms

Name

Location
Sanofi-Aventis Administrative Office Bridgewater, New Jersey  08807