None listed
Conditions
Interventions
Group 1 Type of group
patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
Group name:Group 2 Type of group
patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Response to treatment was defined as complete remission rate (CRR). CRR is complete remission (CR) and morphologic CR with incomplete blood count recovery (residual neutropenia or thrombocytopenia) (CRi). To stop or to proceed with Stage 2 of a given stratum of the Simons optimal 2-stage design was based on the number of patients with CR/CRi and a safety evaluation of the patients from Stage 1 in that stratum. If early results clearly indicated that the drug was not active or worthy of further investigation, enrollment of that particular stratum would be terminated. CR and CRi were assessed by the Investigator according to IWG response Criteria for AML (Cheson et al 2003). As per protocol we would continue to stage II if ≥ 4 patients out of 26 patients enrolled to stage I had a CR or a CRi. As per response observed there was only 1 patient with CR/CRi in stratum A and 2 patients with CR/CRi in Stratum B. Measure:Best Response as Per Investigator Assessment by Stratum (FAS) Timepoints:6 cycles of treatment with a 28-day treatment cycle (Day 168) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:As predefined in the studys protocol, stage II was not pursued due to lack of activity (at end of stage I less than 4 patients in each stratum with CR/CRi) Measure:Partial Response Measured in Stratum A and B Timepoints:6 treatment cycles (28-day/treatment cycle) ; Outcome name:As predefined in the studys protocol, stage II was not pursued due to lack of activity (at end of stage I less than 4 patients in each stratum with CR/CRi) Measure:Time to Remission Measured in Stratum A and B Timepoints:6 treatment cycles (28-day/treatment cycle) ; Outcome name:As predefined in the studys protocol, stage II was not pursued due to lack of activity (at end of stage I less than 4 patients in each stratum with CR/CRi) Measure:Duration of Remission Measured in Stratum A and B Timepoints:6 treatment cycles (28-day/treatment cycle) | — |
Countries
Australia, Belgium, France, Germany, Italy, Korea South, Spain, Switzerland, Turkey, United Kindgdom, United States
Contacts
Public ContactRita Melissa Luna
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed