drugset / Trial / NCT00375193
Study of Amrubicin in Patients With Small Cell Lung Cancer Refractory or Progressive to Prior Therapy
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate the objective tumor response rate of amrubicin when administered as second-line therapy to ED-SCLC patients who have refractory or progressive disease.
Timeline
- Start
- 2006-11-01
- Primary completion
- 2008-05-01
- Completion
- 2009-03-01
Publications
- Background Ettinger DS, Jotte R, Lorigan P, Gupta V, Garbo L, Alemany C, Conkling P, Spigel DR, Dudek AZ, Shah C, Salgia R, McNally R, Renschler MF, Oliver JW. Phase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer. J Clin Oncol. 2010 May 20;28(15):2598-603. doi: 10.1200/JCO.2009.26.7682. Epub 2010 Apr 12.
- Background Spigel DR, et al. Amrubicin (AMR) and cardiotoxicity in second-line treatment of small cell lung cancer (SCLC): A pooled analysis of left ventricular ejection fraction (LVEF) in two phase II trials. 2009 ASCO Annual Meeting, May 29-June 2, 2009, Chicago, IL. Abstract No.e19019. J Clin Oncol 2009;27(suppl)
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amrubicin | Small molecule | 40 mg/m2 | Intravenous |