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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00290953 |
To demonstrate an increase in overall survival for patients with newly diagnosed extended stage small cell lung cancer when treated with SR 48692 versus placebo, after an initial response (complete or partial response or stable) to first line cisplatin plus etoposide.
Primary objective: comparison of overall survival between patients in the control arm and the meclinertant arm.
Secondary objectives: comparison of the progression free survival, the time to progression, the clinical benefit, the quality of life, the toxicity and safety between patients in the control arm and the meclinertant arm.
Condition | Intervention | Phase |
Lung Cancer Pulmonary Neoplasms Small Cell Lung Cancer |
Drug: SR48692 |
Phase II Phase III |
MedlinePlus related topics: | Cancer Lung Cancer |
Drug Information available for: | Etoposide Cisplatin Etoposide phosphate SR 48692 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double Blind, Randomized, Phase II-III Maintenance Study of SR48692 Verus Placebo in Patients With Extensive Stage Small Cell Lung Cancer Following a First Line Chemotherapy With Cisplatin +Etoposide |
Estimated Enrollment: | 620 |
Study Start Date: | October 2002 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |||||
Sanofi-Aventis Administrative Office | |||||
Malvern, Pennsylvania, United States, 19533 | |||||
Argentina | |||||
Sanofi-Aventis Administrative Office | |||||
Buenos Aires, Argentina | |||||
Australia | |||||
Sanofi-Aventis Administrative Office | |||||
Macquarie Park, Australia | |||||
Belgium | |||||
Sanofi-Aventis Administrative Office | |||||
Diegem, Belgium | |||||
Brazil | |||||
Sanofi-Aventis Administrative Office | |||||
Sao Paulo, Brazil | |||||
France | |||||
Sanofi-Aventis Administrative Office | |||||
Paris, France | |||||
Germany | |||||
Sanofi-Aventis Administrative Office | |||||
Berlin, Germany | |||||
Hungary | |||||
Sanofi-Aventis Administrative Office | |||||
Budapest, Hungary | |||||
Italy | |||||
Sanofi-Aventis Administrative Office | |||||
Milano, Italy | |||||
Mexico | |||||
Sanofi-Aventis Administrative Office | |||||
Mexico, Mexico | |||||
Netherlands | |||||
Sanofi-aventis adminsitrative office | |||||
Gouda, Netherlands | |||||
Poland | |||||
Sanofi-Aventis Administrative Office | |||||
Warszawa, Poland | |||||
Russian Federation | |||||
Sanofi-Aventis Administrative Office | |||||
Moscow, Russian Federation | |||||
Spain | |||||
Sanofi-Aventis Administrative Office | |||||
Barcelona, Spain | |||||
United Kingdom | |||||
Sanofi-Aventis Administrative Office | |||||
Guildford Surrey, United Kingdom |
Sanofi-Aventis |
Study Director: | Augustin REY, MD | Sanofi-Aventis |
Related Info 
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Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC3679, SR48692 |
First Received: | February 10, 2006 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00290953 |
Health Authority: | United Kingdom: National Health Service |
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