21 results
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.
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 therapeutic benefit of maintenance pazopanib versus placebo after first line treatment of NSCLC.
The main objective of this pilot study is to determine intratumoral concentrations of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.
To determine the therapeutic effect of vardenafil 10 mg taken twice daily (BID) on Overactive Bladder by means of urodynamic measurements (filling cystometry and pressure flow investigations).
The primary objective is to investigate the effects of intravenous administration of C1INH in human volunteers on cytokine release (TNFa) during endotoxemia. The secondary objective is to determine the effect of administration of C1 INH on…
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 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…
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-…
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…
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 (…
primary• To determine the safety and feasibility of PK guided dosing of pazopanib secondary• Evaluation of the dried blood spot procedure• To determine the objective response rate (according RECIST 1.1)• To determine the time to tumor progression…
Primary Objectives:- To evaluate whether early metabolic response is correlated to clinical benefit (defined as PFS).- To evaluate the effect of age (>= 70 years) on pazopanib pharmacokinetics (AUC0-24hr).Secondary Objectives:- To evaluate…
To determine the plasma pharmacokinetics of Pazopanib after intake of different doses of PazSol001.To determine the preliminary safety and tolerability profile of PazSol001.
- Primary objective: The effect of C1-INH prior to induction of a systemic inflammation by endotoxin (E. coli lipopolysaccharide), on the leukocyte phenotype, activation and mobilization. - Secondary objectives: - Determine the effect of C1-…
A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…
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…