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An open-label multi-center single agent panobinostat rollover protocol for patients who have completed a previous Novartis-sponsored panobinostat study and are judged by the investigator to benefit from continued single agent panobinostat treatment (CLBH589B2402B)

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.

A phase I, open-label, multi-center study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and varying degrees of renal function

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…

A multicenter, randomized, double-blind, placebo controlled phase III study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma

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 +…

A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and various degrees of hepatic function

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…

A phase I/II feasibility study of panobinostat alone and the combination of panobinostat and decitabine prior to donor lymphocyte infusion in recipients of allogeneic stem cell transplantation with poor and very poor risk AML

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…

A phase Ib feasibility study of the combination of panobinostat and midostaurin in recipients of allogeneic stem cell transplantation with FLT3-ITD AML

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…

A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents

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…

Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CPDR001X2102)

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…

European Intergroup Trial on panobinostat maintenance after HSCT for high-risk AML and MDS - A randomized, multicenter phase III study to assess the efficacy of panobinostat maintenance therapy vs. standard of care following allogeneic stem cell transplantation in patients with high-risk AML or MDS (ETAL-4 / HOVON-145)

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 (…