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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00290953




Registration number
NCT00290953
Ethics application status
Date submitted
10/02/2006
Date registered
13/02/2006
Date last updated
23/12/2008

Titles & IDs
Public title
Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide
Scientific title
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
Secondary ID [1] 0 0
EFC3679
Universal Trial Number (UTN)
Trial acronym
SESAME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Pulmonary Neoplasms 0 0
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
- Overall survival (OS)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
- Progression Free Survival (PFS)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
- Time to Progression (TTP)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
- Clinical Benefit assessed by Performance Status and body weight
Timepoint [3] 0 0
Secondary outcome [4] 0 0
- Quality of Life using the LCSS and EuroQoL validated instruments
Timepoint [4] 0 0
Secondary outcome [5] 0 0
- Toxicity and safety assessment using NCI CTC version 2.0
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
* Pathological diagnosis: Histologically or cytologically proven SCLC.
* Disease stage: extensive stage
* Measurable disease by the RECIST criteria is required. Lesions that are present in previously irradiated area are non-measurable unless they have appeared or progressed since completion of the radiation.
* Radiotherapy, if applicable, must have been completed at least 4 weeks before treatment under this protocol and the subject must have recovered from any acute toxicities of radiation.
* Recovered from any surgical procedure(s).
* Calculated creatinine clearance > 55 ml/min using the Cockcroft-Gault formula: Cr Cl in ml/min = (140-age) X (weight in kg) X (1.0 for men or 0.85 for women) / (72 X serum Cr in mg/dl).
* Total bilirubin < two times the upper limit of the normal range at the institution and SGOT/AST < two times the upper limit of normal unless liver metastases are present.
* ANC > 1.5 x 109/L and platelet count > 100 x 109/L.
* Age >18 years.
* Karnofsky Performance Status > 70% .
* Subjects with no prior malignancy, or subjects with cured malignancies other than SCLC if: a) they are alive without disease recurrence for at least 5 years from the date of pathological diagnosis, and b) clinical expectation of disease recurrence is < 5% as documented in the medical record by the responsible physician, and c) they have not received any platinum-based therapy. Subjects with basal cell carcinoma or carcinoma in situ of the cervix may be eligible if adequately treated and clinical expectation of disease recurrence is < 5% as documented in the medical record by the responsible physician.
* Infertile subjects or fertile subjects who use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment. Women of childbearing potential must have documentation of a negative, serum HCG pregnancy test. Subjects must be made aware, before entering this trial, of the risk in becoming pregnant or in fathering children.
* Signed written informed consent (approved by the Ethics Committee) obtained prior to study entry.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Limited disease.
* Symptomatic brain metastases: a patient with brain and/or leptomeningeal metastases on computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan may be included only if he/she is asymptomatic on neurologic exam and is not receiving corticosteroid therapy to control symptoms.
* Concurrent active cancer, including cancer stable on adjuvant therapy.
* Prior immunotherapy, biological therapy or chemotherapy for SCLC.
* Radiotherapy: Prior radiation to non-symptomatic or non-life-threatening sites.Prior radiation therapy to all potential indicator lesions. Prior radiation therapy to some but not all indicator lesions is allowed.
* Class III or IV congestive heart failure according to the New York Heart Association Classification.
* History of allergic reactions to appropriate diuretics or antiemetics (e.g., 5-HT3 antagonists) to be administered in conjunction with protocol-directed chemotherapy.
* Uncontrolled intercurrent illness.
* Lactating or pregnant women.
* Received any investigational drug within 30 days before beginning treatment with study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
432
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Belgium
State/province [2] 0 0
Diegem
Country [3] 0 0
Brazil
State/province [3] 0 0
Sao Paulo
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Hungary
State/province [6] 0 0
Budapest
Country [7] 0 0
Italy
State/province [7] 0 0
Milano
Country [8] 0 0
Mexico
State/province [8] 0 0
Mexico
Country [9] 0 0
Netherlands
State/province [9] 0 0
Gouda
Country [10] 0 0
Poland
State/province [10] 0 0
Warszawa
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Moscow
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00290953
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00290953