18 results
Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…
The main objective of the study is to investigate whether the strong clinical effects of natalizumab in RRMS can be explained by enhanced functional adaptation mechanisms of the brain and whether enhanced functional reorganisation is sustained over…
The primary objective of the phase IB part is to establish the maximum tolerated dose for pazopanib in combination with paclitaxel and carboplatin given weekly in a group of patients with platinum-refractory or -resistant ovarian, fallopian tube or…
Primary objectivesThe primary objective is to assess the progression-free survival (PFS) of patients who receive bi-monthly rotations of Pazopanib and Everolimus versus patients who receive Pazopanib as a first line treatment. Secondary…
Natalizumab (Tysabri®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes
The primary objective of the study is the functional improvement with one point or more on the modified Rankin scale after the 12th week of natalizumab (compared to baseline).
The main objective of this pilot study is to determine the biological impact of treatment with targeted agents at the systemic and local tissue level in relation to toxicity.
To investigate if high-dose ribavirin in combination with peginterferon alfa-2a can improve outcome in treatment naïve hepatitis C patients with genotype 1 or 4 and a high viral load (>400.000 IU/ml).
Primary objectiveTo evaluate the effect of PK-guided individualized dosing of pazopanib on the interindividual variability in drug exposure.Secondary objective- To determine the correlation between pazopanib trough and exposure levels - To determine…
To determine the relation between tumor tissue phosphoproteomic profiles and progression-free survival (PFS) in patients with advanced RCC
To compare the efficacy of erythropoietin beta administered weekly using an early start approach (Hb * 7.2 mmol/l) with standard starting approach (Hb * 6.2 mmol/l) in subjects with lymphoproliferative malignancy, receiving chemotherapy during a 16-…
Primary:To evaluate if progression-free survival from randomization to progression or death during second-line therapy (total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib.Secondary:1. Time from…
The primary objective of the phase II is to determine the progression free survival (PFS) at 1 year according to the RECIST 1.1 of the combination of pazopanib with weekly paclitaxel and carboplatin in platinum-resistant ovarian, fallopian tube or…
Part APrimary objective:To determine the equivalent dose of pazopanib when taken with a continental breakfast compared to 800 mg in fasted state.Secondary objective:To monitor the occurrence of adverse events of pazopanib with and without food…
Primary objective- To evaluate the efficacy of lenalidomide (RevlimidTM) in low/int-1 risk MDS with or without a treatment with Epo (NeoRecormonTM)/G-CSF (NeupogenTM) in terms of hematological improvement (HI) as defined by the modified response…
Based on the above, we propose to perform a prospective pharmacokinetic cross-over trial to test the hypothesis that splitting pazopanib intake moment will increase Cmin and AUC0-24h. In addition, we will show that this is a feasible, safe and cost-…
Our main objective is to prove that extending dose intervals guided by serum concentrations of natalizumab, will not result in radiological or clinical disease activity.
Primary Objective- To explore the effects of NeoRecormon on well-trained cyclists and their cycling performance by exercise parameters. Secondary Objectives- To explore the effects of NeoRecormon on well-trained cyclists and their cycling…
The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…