Lung CancerPhase 2/3SESAMENCT00290953
Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide
A Phase 2/3 study testing SR48692 in people with Lung Cancer and Pulmonary Neoplasms, run by Sanofi at 14 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pulmonary Neoplasms, Small Cell Lung Cancer
- What is being tested?
- SR48692
- How many people
- 432 participants
- Where
- 14 sitesin 14 countries
- Study dates
- Oct 2002to Mar 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
14 sites in 14 countries.
14 sites in 14 countries
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official 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
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.
- Conditions
- Lung Cancer, Pulmonary Neoplasms, Small Cell Lung Cancer
- Being tested
- SR48692
- Keywords
- Metastases
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR48692Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Overall survival (OS)
Secondary outcomes (5)
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startOct 2002
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290953
- Sponsor's protocol ID
- EFC3679
- Acronym
- SESAME
- Status last verified
- Dec 2008
- First submitted
- 10 Feb 2006
- Last updated
- 23 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00290953
- Acronym / sponsor ID
- SESAME / EFC3679
- Conditions
- Lung Cancer, Pulmonary Neoplasms, Small Cell Lung Cancer
- Keywords
- Metastases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 13 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR48692 | Drug | – |
Primary outcome
- Overall survival (OS)
5 secondary outcomes
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2008.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
14 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SR48692 in people with Lung Cancer and Pulmonary Neoplasms, run by Sanofi at 14 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Argentina, Australia, Belgium, Brazil, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Overall survival (OS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2008.