17 results
Primary objective is to determine the plasma pharmacokinetics of ModraCape001 and compare these to the pharmacokinetic profile of Xeloda®.Secondary objectives are:• To determine the AUC in blood plasma of capecitabine and its metabolites 5-dFCR, 5-…
Part A Food Effect StudyPrimary Objective• To determine the effect of a high fat meal on oral bioavailability of 50 mg E7820 in comparison with fasting conditions.Secondary Objectives• To determine the safety and tolerability of E7820.• To determine…
2.5 Study rationaleThe nephrotoxicity caused by cisplatin is of great concern both in that it is dose-limiting and can be detrimental to the patient. Much work has been done to reduce or prevent this damage to renal cells, however to date the best…
Primary objective:To assess the puncture free survival after start of treatment with cediranib (time to first need for paracentesis or thoracentesis or time to death, which event occurred first)Secondary objectives:-To assess the palliative effects…
The primary objective is to determine the maximum tolerated dose (MTD) of docetaxel (as ModraDoc001) that can safely be administered to patients with cancer in a bi-daily weekly schedule.
To quantitatively determine the absorption and excretion of docetaxel (as ModraDoc005 10 mg tablets) after administration of a single low dose and a single high dose of oral docetaxel in combination with ritonavir.
Primary: * To determine the effect of food on the bioavailability of E7050 following oral administration of a tablet containing 100 mg E7050 with and without a standard low- or high-fat breakfast (Part A)* To characterize E7050 pharmacokinetics…
Primary objective:•To compare the pharmacokinetic (PK) profiles of gemcitabine-5*-elaidate (parent compound) of two formulations of CO-1.01 in order to investigate whether the confidence interval (CI) for the ratio of the AUC0-* of the two…
To evaluate the efficacy of AD 923 in comparison to MSIR in the management of breakthrough pain in subjects with malignicies who are taking a stable dose of background opioids.
Compare Progression Free Survival (PFS) for brivanib versus placebo in subjects with advanced solid tumors with FGF-2 over-expression and who have obtained stable disease after 12 weeks of treatment with brivanib separately for each tumor.
Primary Objective: Compare achievement of glycemic control in SSI therapy and NPH insulinGlycemic control is defined as the proportion of glucose measurements within target range (Fasting target glucose 3.9 * 7.8 mmol/l. Random target glucose 3.9-10…
To determine if there is a difference in the pharmacokinetics of low-dose cisplatin with and without prehydration.
This study has been transitioned to CTIS with ID 2023-509881-39-00 check the CTIS register for the current data. The aim of this study is to evaluate the difference in the fraction of patients that have disease progression within 6 months after…
This study has been transitioned to CTIS with ID 2024-515604-39-00 check the CTIS register for the current data. The purpose of this research study is to learn about the safety and effectiveness of 177Lu-PNT2002, an investigational agent being…
To determine the food-effect of a standardised Dutch breakfast on the pharmacokinetics of oral alectinib (Alecensa®), especially Cmax, AUC and relative bioavailability, at steady state using a stable isotopically labelled microtracer approach.
Primary Objectives:Part 1- Estimate the relative bioavailability of the tablet formulation of TAK-931 in reference to the PIC formulation.Part 2- Assess the effect of a high-fat meal on the single dose PK of TAK-931 administered as the tablet…
To determine the effect of a high-fat meal on the exposure to docetaxel given as ModraDoc006 tablets in combination with ritonavir in patients with cancer.