A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy - AMR PH GL 2007 CL 001

PHARMION CORPORATIO0 个研究点目标入组 480 人开始时间: 2008年4月11日最近更新: 2012年8月7日

试验速览

暂无简介。

•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 to first-line platinum-based chemotherapy, with subsequent progression ≥ 90 days after completing chemotherapy) or refractory (defined as no objective response to prior platinum-based therapy or progression < 90 days after completing prior platinum-based therapy); 3. Extensive or limited disease; patients with limited disease who are candidates for local or regional salvage radiation therapy must have been offered such treatment prior to participation in this study; 4. Radiographically documented progression after first-line treatment with platinum-based chemotherapy; 5. No more than 1 prior chemotherapy regimen; 6. At least 18 years of age; 7. ECOG performance status of 0, 1, or 2.
•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

•1. 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; 2. Prior anthracycline, topotecan, or irinotecan treatment.

发起方

PHARMION CORPORATIO