15 results
The primary objective of this trial is to investigate the bias, limits of agreement and percentage error of cardiac output measurements with Vigileo FloTrac, transoesophageal doppler ultrasound, thoracic bioreactance (NICOM) with the CO obtained…
Primary: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.
Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.
The primary objective is to characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.The secondary objectives are to evaluate the safety and tolerability of belimumab 200 mg SC in pediatric SLE participants and to…
Primary: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity of…
Primary: 1/ To determine the higher of the tolerated dose of INC280 tablets with food between 300 and 400 mg BID in patients with cMET dysregulated advanced solid tumors. 2/ To assess the PK of INC280 with food.Secondary: To assess the safety of…
The aim of this prospective, multicentre randomized phase II study is to evaluate the safety and efficacy of the combination of capmatinib and spartalizumab in subjects with EGFR weight (for exon 19 deletions and exon 21 L858R substitution mutations…
Primary phase 1: To determine MTD and/or RP2D of INC280 incombination with erlotinibPrimary phase 2: To compare the antitumor activity of INC280 alone, and INC280 in combination with erlotinib, vs platinum with pemetrexed, as measured by Progression…
Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.
The primary objective is to assess whether combination treatment BLM+RTX will lead to reduced treatment failure and the improvement of pivotal, SLE-specific autoimmune phenomena compared SLE patients treated with standard of care.
* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…
The primary goal of this study is to investigate the effects of belimumab on the composition of lymph nodes and the inflamed synovial tissue as well as (subsets of) immune cells in the peripheral blood. In addition, we will identify immunological…
In this study, we want to find out whether the new drug capmatinib is more effective (i.e. better inhibits the growth of cancer cells) than the widely used chemotherapy docetaxel. In addition, it will be assessed whether treatment with capmatinib is…
Primary: To evaluate the antitumor activity of INC280, as measured by overall response rate (ORR) as by a blinded independent review committee, by cohort.Secondary: Duration of response (DOR), ORR and DOR by investigator, time to response (TTR),…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)