9 results
Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…
Primairy objective:• To determine the safety, tolerability and pharmacokinetics of 2B3-201, and in comparison to free methylprednisolone hemisuccinate and placebo;Secundairy objective:• To determine the pharmacodynamic effects of 2B3-201 on CNS…
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus for 9 months (6 months of full therapy and 3 months of tapering doses) followed by a dose of RTX leads to a greater increase in the proportion of primary MN patients with…
Primary: To provide metastatic colorectal cancer patients with access to aflibercept and todocument the overall safety in these patientsSecondary: To document the Health-Related Quality of Life of aflibercept in this patientpopulation
The primary objective of this study is to evaluate the efficacy of optimized thiopurine therapy. Secondary objectives are a cost-utility and budget impact analysis of optimized thiopurine therapy and the identification of biomarkers in mucosal…
To assess the effect of two withdrawal strategies over two years in patients with stable remission for more than 8 months on combination therapy with infliximab and antimetabolites, and demonstrate that continued combination of infliximab and…
Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…
Main objective of this project is to establish the maximum tolerable dose (MTD) and recommended phase II dose of intraperitoneal irinotecan in patients with PC of colorectal origin, added to standard of care systemic chemotherapy. Other endpoints…
To compare the effect on cognition of treatment with clobazam or corticosteroids.