NCT00290953|CompletedPhase 2

Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide

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

Sanofi ClinicalTrials.gov

Compare

1 other identifier

EFC3679

Study Type

interventional

Target

432

Locations

14 countries

Sites

Timeline

RegisteredFeb 2006

StartedOct 2002

CompletionMar 2006

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

432

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline

Completed

Started Oct 2002

Geographic Reach

14 countries

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.4 years study duration

Study Start

First participant enrolled

October 1, 2002

Completed

3.4 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed

16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed

Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

3.4 years

First QC Date

February 10, 2006

Last Update Submit

December 22, 2008

Conditions

Lung Cancer Pulmonary Neoplasms Small Cell Lung Cancer

Keywords

Metastases

Outcome Measures

Primary Outcomes (1)

- 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

Interventions

SR48692DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.