12 results
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…
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 +…
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 Safety Objective: • To evaluate initial safety of UCon for treatment of OAB symptoms in a home setting.Secondary Safety Objective• To demonstrate that subjects using UCon do not experience an unacceptable amount of device- or procedure…
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.
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…
To determine whether [18F]FES PET/CT improves staging for women with clinical stage II/III or LRR, ER+ breast cancer as compared to standard [18F]FDG PET/CT.
- part A: to identify the pharmacokinetic model that represents the [18F]FES kinetics most optimally and to validate simplified quantitative parameters of [18F]FES uptake. - part B: to investigate the repeatability of simplified quantitative…
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 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 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 (…