A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
- Conditions
- -C92 Myeloid leukaemiaMyeloid leukaemiaC92
- Registration Number
- PER-137-09
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 1
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method