Phase 2
N=59
Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
Refractory Leukemia · Acute Myelogenous Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00880269 ↗Enrolled (actual)
59
Serious AEs
88.1%
Results posted
Sep 2016
Primary outcome: Primary: Best Response as Per Investigator Assessment by Stratum (FAS) — 3.1; 7.4; 0; 3.7 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Panobinostat/LBH589 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Response as Per Investigator Assessment by Stratum (FAS) |
3.1; 7.4; 0; 3.7; 3.1; 3.7 | — |
| SECONDARY Partial Response Measured in Stratum A and B |
— | — |
| SECONDARY Time to Remission Measured in Stratum A and B |
— | — |
| SECONDARY Duration of Remission Measured in Stratum A and B |
— | — |
| SECONDARY Event-free Survival Measured in Stratum A and B |
— | — |
| SECONDARY Overall Survival Measured in Stratum A and B |
— | — |
Summary
This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Other Protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00880269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.