12 results
Primary: To allow continued use of panobinostat to patients receiving single agent therapy with panobinostat in a Novartis-sponsored study.Secondary: To collect long term data on SAEs.
As results from a recently completed radio-labeled human ADME study [CLBH589B2108] in patients indicated that both kidney and liver are involved in the elimination and metabolism of panobinostat, understanding the impact of altered organ function…
Primary:to investigate the effects on heart rate (HR) and rhythm of concomitant administration of the study drug with a calcium-channel blocker (CCB) or a beta-blocker (BB)Secondary:- to investigate the effects on blood pressure (BP) of concomitant…
Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this phase III study is to compare treatment with bortezomib/dexamethasone + panobinostat to bortezomib/dexamethasone +…
Primary:to evaluate the effects of a moderate CYP3A4/5 inhibitor, diltiazem on the pharmacokinetics and pharmacodynamics (Thrombin and TRAP-induced platelet aggregation) of the study drug and its known metabolitessecundary:to evaluate the effects of…
Primary:To assess the effect of various degrees of impairment in hepatic function as measured by NCICTEPcriteria, on the pharmacokinetics of panobinostat.Secondary:To assess the effect of various degrees of hepatic functions on the safety of…
The aim is to study safety and activity of nelfinavir, added to standard chemoradiotherapy (26x1.8 Gy and capecitabine 825 mg/m2 BID) in patients with locally advanced rectal cancer. Furthermore analysis of the effect of nelfinavir combined with…
Primary: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus, HDM201, QBM076 or panobinostat and to identify recommended doses and schedules for future studies.Secondary: To characterize changes in the immune…
Primary objective:Part I- To asses the feasibility of addition of post-transplant panobinostat combined with decitabine to a regimen of T-cell replete RIC alloHSCT in patients with very poor risk AML/RAEB, and select the dose level for the phase II…
Primary objective:To asses the safety and feasibility of post-transplant panobinostat combined with midostaurin in patients with adverse risk AML/RAEB with FLT3-ITD with high allelic ratio in terms of dose limiting toxicity.Secondary objectives:To…
Primary: To assess best overall response rate (ORR) up to 8 cycles. Secondary: ORR, complete response (CR), very good partial response (VGPR), progression free survival (PFS), overall survival (OS), safety, PK, exposure-response (efficacy and safety…
Primary objective* To determine the efficacy of panobinostat maintenance therapy versus standard of care administered to patients with high-risk MDS or AML in complete hematologic remission after an allogeneic hematologic stem cell transplantation (…