Small Cell Lung Cancer (extensive stage) MedDRA version: 8.1 Level: LLT Classification code 10041068 Term: Small cell lung cancer extensive stage
Conditions
Interventions
Product Name: Amrubicin
Product Code: CNF3140
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Amrubicin
Current Sponsor code: CNF3140
Concentration unit: mg milligram(s)
Co
Sponsors
Celgene International SARL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically/cytologically proven small cell lung cancer Extensive disease as defined by Davis et al WHO performance status 0-2 Measurable disease according to RECIST criteria (imaging within 28 days prior to entry) Age = 18 years Normal baseline cardiac function No prior systemic chemotherapy for small cell lung cancer No radiotherapy for SCLC within 14 days before treatment Adequate haematological function (WBC >1.5 x 10^9 /L, platelets >100 x 10^9 /L, Hb> 9 g/dL) Creatinine clearance: = 60ml/min (Cockroft and Gault) Adequate hepatobiliary function (ALT/AST 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix Absence of uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, clinical significant pericardial disease or cardiac amyloidosis. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial No pregnancy or breast feeding. Men and Women of child bearing potential must use an appropriate method of contraception if the risk of conception exists Written informed consent before randomization, according to ICH/EU GCP, and national/local regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of the study is the overall response rate. ;Secondary Objective: Secondary endpoints will include toxicity of treatment (including cardiotoxicity), progression-free survival (PFS) and overall survival (OS). These endpoints will be reported in a descriptive way.;Primary end point(s): Primary end point is overall response rate. | — |
Countries
Belgium, Italy, Netherlands, United Kingdom
Outcome results
None listed