30 results
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…
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
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 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 objectivesTo confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs. placebo significantly increases trough FEV1 (defined as mean evaluation at 23 h 15 min and 23 h 45 min post dose) following 12 weeks of treatment in patients with…
Primary objective: To demonstrate that QVA149 (110/50 *g o.d.) is superior to NVA237 (50 *g o.d.) with regard to the rate of moderate to severe COPD exacerbations during 64 weeks of treatmentSecondary objectives: To demonstrate that QVA149 (110/50 *…
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 objectiveTo evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the…
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…
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
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…
Main objective of the study is to find out whether short duration pulses of blue light at high intensity in the morning are capable of inducing a phase advance of the circadian system.
Primary objective: To demonstrate the superiority of QVA 110/50 µg compared to both QAB149 150 µg and NVA237 50 µg in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 26 weeks of treatment in patients with moderate to…
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.*…
Primary: To characterize safety and tolerability of MIW815 (ADU-S100) given with PDR001 and identify recommended doses and schedule for future studies.Secondary: Anti-tumor activity. Pharmacodynamics (PD). Pharmacokinetics (PK).
To assess the feasibility of ZW800-1 in the intraoperative assessment of kidney and ureter perfusion during kidney transplantations (living donor nephrectomy and transplantation)
To assess safety, tolerability, and PK of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and Budigalimab in subjects with R/M HNSCC.
We aim to assess differences in the in vivo distribution of CD8+ T-cells in patients with proven SARS-CoV-2 presenting with lymphopenia or with normal lymphocyte counts, using [89Zr]Zr-Df-IAB22M2C PET/CT imaging. Elucidating the pathophysiology…
Primary objectivesPhase I:To determine the recommended phase 2 dose (RP2D) of the dacomitinib-PD-0325901 combination in patients with KRASm NSCLC Phase II:To determine the progression free survival of the dacomitinib/PD-0325901 combination compared…
Primary objectives Phase Ib: To estimate the MTD and/or RP2D of LGX818 in combination with cetuximab ± BYL719. Incidence of dose-limiting toxicities (DLTs). Phase II: To compare the efficacy of the dual (LGX818, cetuximab) and triple (LGX818, BYL719…