Extensive Disease Small Cell Lung Cancer that is refractory or progressive 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
Other descriptive name: Amrubicin hydr
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all the following criteria for inclusion into the study at the time of screening. 1. Histological or cytological diagnosis of SCLC;extensive-disease (ED) at the time of study entry 2. Refractory to first-line platinum-based chemotherapy (i.e., has received one prior platinum-based chemotherapy regimen) defined as one of the following: a. Best response to first-line chemotherapy is radiographically documented progression (refractory disease) b. Best response to first-line chemotherapy is radiographically documented response or stable disease, with subsequent documented progression during continuing chemotherapy (resistant relapse) c. Documented progression within 90 days of completion of first-line chemotherapy (last dose of chemotherapy), regardless of best response to treatment (resistant relapse) 3. At least 18 years of age 4. ECOG Performance Status of 0, 1, or 2 5. Measurable disease defined by RECIST criteria. a. Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology and/or cytology b. Measurable lesion: Lesions that can be accurately measured in at least one dimension with the longest diameter = 20 mm using conventional techniques or = 10 mm using spiral CT scans. CT (including spiral CT) scans and MRI are the preferred methods of measurement; however, chest x-rays are acceptable if the lesions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required. 6. Adequate organ function including the following: • Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) greater or equal to 1500 cells/µL, platelet count greater or equal to 100,000 cells/µL and hemoglobin greater or equal to 9 g/dL • Hepatic: bilirubin less than or equal to 1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3.0 X ULN. • Renal: serum creatinine less than 2.0 mg/dL or calculated creatinine clearance more than 60 mL/min • Cardiac: Left ventricular ejection fraction (LVEF) greater or equal to 50% by MUGA or echocardiography (intra-patient reassessment of LVEF should be performed via the same method throughout the study). 7. Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-producing potential, use of effective contraceptive methods during the study. 8. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments 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: Patients will be excluded from the study if any of the following apply: 1. Pregnant or nursing women 2. Chest radiotherapy within the previous 28 days or other radiotherapy within the previous 14 days. Recovery from the acute toxic effects of radiation required prior to study enrollment. Measurable lesions that have been previously irradiated must be enlarging to be considered target lesions. Prior radiation therapy allowed to < 25% of the bone marrow. 3. More than 1 prior chemotherapy regimen for SCLC 4. Prior anthracycline treatment 5. Treatment with any investigational agent within 28 days or standard chemotherapy within 21 days prior to first dose. Patients must have recovered from all acute adverse effects of prior therapies, excluding alopecia. 6. Patients with second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 2 years previously with surgery and/or radiotherapy and no evidence of recurrence since that time). 7. Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study. 8. Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for at least 2 weeks and off corticosteroids for at least 1 week. 9. History of interstitial lung disease or pulmonary fibrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is the objective tumour response rate (RECIST). ;Secondary Objective: • Duration of overall response • Time to tumor progression (TTP) • Progression free survival (PFS) • Overall survival • Toxicity profile • Incidence of cardiomyopathy • Pharmacokinetic parameters There are also exploratory objectives: • ORR based on prior response to first-line therapy • Disease control rate (ORR by RECIST plus SD x 12 weeks) • Duration of disease control;Primary end point(s): Objective tumor response rate (RECIST). | — |
Countries
Netherlands, United Kingdom
Outcome results
None listed