19 results
Primary Objective:To investigate the proportion of patients with resection specimens demonstrating induction of a pathological (near) complete remission (* 95% tumor regression)Secondary Objectives:To study tumour changes to pre-operative pazopanib…
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 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…
To study the safety and feasibility of adding 6 weeks of orally administered Pazopanib to 25 x 2Gy in 5 weeks preoperative radiotherapy in soft tissue sarcoma patients (to identify the Dose Limiting Toxicity (DLT) and the Recommend Phase II Dose (…
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…
The purpose of the study is to investigate the maximum effect of ADASUVE on repolarization of the heart. This is the process where the cells of the heart muscle recharge again after contraction. If this process is strongly slowed down, (potentially…
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-…
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…
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 purpose of the study is to investigate the effect of CBD on specific ECG parameters. Importantly, it will be evaluated if there is a prolongation of the QT interval. When the QT interval is prolonged, repolarization of the heart is delayed. This…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
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…
Primary Objective: The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose of 600 and 800 mg MFX. Secondary Objectives: * To evaluate limited…
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.
The purpose of part A of the study is to investigate how safe the study drug is and how well the study drug is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body. The…
To determine the relation between tumor tissue phosphoproteomic profiles and progression-free survival (PFS) in patients with advanced RCC
The primary objective is to compare the efficacy of moxifloxacin 400 mg PO OD for five days with the respective efficacy of amoxicillin clavulanic acid 875/125 mg PO BID for seven days in the treatment of subjects with AECB. The primary efficacy…
The primary objective of the study is to reject the Null hypothesis: A 7 to 21 day therapy with moxifloxacin, 400 mg once daily is more than 10 % less effective than a 7 to 21 day therapy with piperacillin/tazobactam three times daily possibly…
Study A: Safety of intranasal administration of palivizumab in healthy adultsStudy B: Effect of local administration of palivizumab on prevention of RSV infection