A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (VITAL)
Tracking Information
Start Date ICMJE | September 2007 |
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Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 21, 2008) | Overall Survival [ Time Frame: Study period ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: September 19, 2007) | Overall Survival |
Change History | Complete list of historical versions of study NCT00532155 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: August 21, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: September 19, 2007) |
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Descriptive Information
Brief Title ICMJE | A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer |
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Official Title ICMJE | A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated With Second-Line Docetaxel After Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer |
Brief Summary | The primary objective of the study is to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The secondary objectives are to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this patient population and to determine immunogenicity of IV aflibercept (anti- aflibercept antibody detection) in all patients. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 900 | ||||
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Estimated Completion Date | October 2010 | ||||
Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Korea, Republic of, Malaysia, Netherlands, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Sweden, Taiwan, Turkey, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00532155 | ||||
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Responsible Party | ICD Study Director, sanofi-aventis | ||||
Study ID Numbers ICMJE | EFC10261, EudraCT 2007-000819-29 | ||||
Study Sponsor ICMJE | Sanofi-Aventis | ||||
Collaborators ICMJE | Regeneron Pharmaceuticals | ||||
Investigators ICMJE |
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Information Provided By | Sanofi-Aventis |
Source: http://clinicaltrials.gov/