12 results
A pilot study to:1. assess the urodynamic changes induced by 100mg MR formulationof UK-369,003 vs. placebo in men with LUTS;2. Assess the safety and tolerability of UK-369,003 in men with LUTS
Primary1. To assess the major (complete/partial) cytogenetic response (MCyR) rateSecondary1. To determine the duration of MCyR2. To determine the complete hematologic response (CHR) rate3. To determine the complete cytogenetic response (CCyR) rate4…
Primary objective(s)Phase Ib:-Define the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab in patients with advanced or metastatic HER2-positive breast cancers.Phase II:-Evaluate…
Primary To determine the MTD of LDK378 (oral administration) as a single agent Secondary* Safety and tolerability of LDK378* To characterize single and multiple-dose PK of LDK378.* To assess preliminary anti-tumor activity of LDK378
This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…
The purpose of this phase Ib study is to determine the maximum tolerated dose (MTD) of i.v. and oral panobinostat when given in combination with trastuzumab and paclitaxel. Additional patients will be enrolled at the MTD to further evaluate the…
The main objective of this study is to compare the incidence of KPTD in mildly renally impaired HBV-infected persons on TDF to the incidence in patients with normal renal function. Secondary goals are to relate tenofovir plasma, intracellular and…
This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…
Primary* To determine the maximum tolerated dose or recommended phase 2 dose of oral BYL719 as single agent and in combination with fulvestrantSecondary* To assess the overall safety and tolerability of BYL719 as single agent and in combination with…
Primary To determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLT) of LEE011 when administered orally once daily for 21 consecutive days followed by a 7 day break.Secondary *Safety and tolerability of LEE011.*…
The primary objective of the study is to determine the MTD (maximum tolerated dose) and/or RDE (recommended dose for expansion) of BGJ398 in combination with BYL719.The secondary objectives are to characterize the safety and tolerability of BGJ398…
Objective(s): Part 1: To determine the safety, tolerability, pharmacokinetics (PK), and efficacy of single ascending doses of OPC-108459 following one 10-minute constant rate infusion in adultsubjects diagnosed with paroxysmal or persistent AF. Part…