18 results
Primary objective: to compare the effect two immunosupressive therapy regimens on GFR estimated by iohexol clearance at week 52 post kidney transplantationSecundary objective: to compare the safety and efficacy profiles of the two immunosupressive…
To investigate if concomitant and adjuvant temozolomide chemotherapy improves survival in elderly patients that are managed with a short course of radiotherapy.
To decrease the cumulative incidence of (hematological) relapse
To determine if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by overall survival.
The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure. Secondary objective is the quality of life and effect on intestinal permeability.
- to determine the recommended phase 2 dose of TG02 in combination with radiotherapy in older patients (>65 years of age) with IDHwt glioblastoma and anaplastic astrocytoma without MGMT promoter methylation- to determine the recommended phase…
To assess the efficacy and safety of mycophenolate mofetil as induction therapy in patients with treatment naive autoimmune hepatitis.
• To characterize the systemic response to mucosal immunization with an oral cholera vaccination challenge.• To characterize the local response to intranasal rechallenge after cholera vaccination as outcome measure for nasal mucosal immunity.• To…
The primary objective of the study is to assess the progression-free survival (PFS) of oralveliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel.The…
This study will investigate whether treatment with Nivolumab in combination with radiation therapy, is comparable to Temozolomide in combination with radiation therapy in patients with Unmethylated MGMT Glioblastoma. We will measure this by…
- to evaluate the FVIIa activity PK of 2 CSL689 dose levels in subjects with congenital FVII deficiency- to determine the PK characteristics of FVIIa activity of CSL689- to evaluate the safety and tolerability of intravenous administration of CSL689
To determine the best treatment for anaplastich oligodendroglial tumors with combined 1p/19q loss, and to determine the optimal treatment with respect to the maintenance of a maximal neurological and cognitive functioning.
Primary objective:• Evaluate PK parameters of the oral suspension of temozolomide in the paediatric population aged 1 year and over.Secondary objectives:• Evaluate the safety of the oral suspension of temozolomide,• Evaluate the acceptability of the…
Objective(s)* To investigate the pharmacokinetic behaviour of a single dose of MMF;o Plasma concentrationso Cellular concentrationso Relationship between plasma and cellular concentrations* To investigate the pharmacodynamic effects of a single dose…
Determine whether early postoperative treatment results in a longer survival without further treatments and in the end a longer overall survival, and whether earlier treatment results in the earlier occurence of delayed adverse effects of treatment
Primary objectives:Phase 1b:Arm A (BGB-290 + radiation therapy [RT]): Subjects with first-line glioblastoma (GB) with unmethylated MGMT promoter (*unmethylated GB*)• To assess safety and tolerability of BGB-290 combined with RT• To identify dose-…
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…
This is a phase I study of hydroxyurea and dose-intense temozolomide in patients with recurrent glioblastoma that are elegise for re-challenge temozolomide.Primary Objective: To determine the maximal tolerated dose and safety profile of daily…