A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 1 人开始时间: 2010年2月17日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Written informed consent prior to study-specific screening procedures
•Life expectancy of = 60 days
•Eastern Cooperative Group (ECOG) performance status = 2
•Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)
•Negative serum pregnancy test (within 7 days of first dose)
•Negative urine pregnancy test immediately prior to first dose

•Known HIV
•Psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
•Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes
•Female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
•Male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment
•Patient unable to swallow capsules
•Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat

发起方

OVARTIS BIOSCIENSES PERU S.A.,