Extensive or limited and sensitive or refractory SCLC after failure of first-line chemotherapy. MedDRA version: 9.1 Level: LLT Classification code 10041071 Term: Small cell lung cancer stage unspecified
Conditions
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed; 2. SCLC that is either sensitive (defined as a response, including stable disease, to first-line platinum-based chemotherapy, with subsequent progression = 90 days after completing first-line chemotherapy) or refractory (defined as progressive disease as best response to first-line platinum-based chemotherapy or progression 60 mL/min, d. Cardiac: Left ventricular ejection fraction (LVEF) = 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA); 10. Negative serum pregnancy test at the time of enrollment for females of childbearing potential; 11. For males and females of child-producing potential, use of effective contraceptive methods during the study; 12. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, to understand and complete QoL forms, 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 meeting any of the following criteria will be excluded from the study: 1. Pregnant or nursing females; 2. Chest radiotherapy with curative intent to the primary disease complex = 28 days prior to first dose; cranial radiotherapy = 21 days prior to first dose; radiotherapy to all other areas = 7 days prior to first dose; 3. Prior anthracycline, topotecan or irinotecan treatment; 4. 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; 5. Patients with previous malignancy treated with chemotherapy and/or radiation (except in situ carcinoma of the cervix, localized low-grade prostate cancer, adequately treated non-melanomatous skin cancer, or ductal carcinoma in situ [DCIS] of the breast). Patients with a previous malignancy that was treated surgically at least 3 years prior and who have been in remission since that time will be allowed; 6. Concurrent severe or uncontrolled medical disease (eg, 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; 7. Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable for = 2 weeks after radiotherapy ; if the patient is on corticosteroids, the dose of corticosteroids must have been stable for = 2 weeks prior to first dose of study treatment, or be in the process of being tapered; 8. Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis not related to prior treatment. 9. Patients with known history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate superiority in overall survival of amrubicin (40 mg/square metre administered as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course) compared with topotecan (1.5 mg/square metre administered as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course) in patients with extensive or limited and sensitive or refractory small cell lung cancer (SCLC) after failure of first-line chemotherapy.;Secondary Objective: The important secondary objectives are to further characterize the clinical benefit of amrubicin compared with topotecan in terms of the following: • Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST); • Progression-free survival (PFS); and • Duration of response. Additional secondary objectives are to assess or compare the effect of amrubicin relative to topotecan in terms of the following: • Time to tumor progression (TTP); • Quality of life (assessed using EuroQol [EQ-5D] and the Lung Cancer Symptom Scale [LCSS]); • Safety; and • Pharmacokinetics (plasma and whole blood concentrations) in amrubicin-treated patients only.;Primary end point(s): Overall survival will be the primary endpoint for this study | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed