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SESAME
A Double Blind, Randomized, Phase II-III Maintenance Study of SR48692 Versus Placebo in Patients With Extensive Stage Small Cell Lung Cancer Following a First Line Chemotherapy With Cisplatin + Etoposide
Sponsor study identifier
interventional
432
14 countries
14
Study Start
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2006
Actual (reported)Study Completion
March 2006
Actual (reported)To demonstrate an increase in overall survival for patients with newly diagnosed extended stage small cell lung cancer when treated with SR48692 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
February 10, 2006
Actual (reported)February 13, 2006
Actual (reported)March 2006
Actual (reported)March 2006
Actual (reported)- Overall survival (OS)
- Progression Free Survival (PFS)
- Time to Progression (TTP)
- Clinical Benefit assessed by Performance Status and body weight
- Quality of Life using the LCSS and EuroQoL validated instruments
- Toxicity and safety assessment using NCI CTC version 2.0
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
São Paulo, Brazil
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Budapest, Hungary
ICD CSD
Sanofi
432 participants (actual enrollment reported by the registry).
First Submitted
February 10, 2006
First Posted
February 13, 2006
Study Start
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
México, Mexico
Sanofi-aventis adminsitrative office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Warsaw, Poland
Sanofi-Aventis Administrative Office
Moscow, Russia
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Primary Completion
March 2006
Actual (reported)Study Completion
March 2006
Actual (reported)Last Updated
December 23, 2008
Record last verified: 2008-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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