31 results
Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical
Trial (FACT)
Primary ObjectiveThe overall aim is to evaluate a new preeclampsia (PE) prevention strategy: 4.0mg (1.0mg x 4) of folic acid supplementation vs. placebo from early (80/7 to 166/7 weeks of gestation) pregnancy until delivery.Secondary ObjectivesTo…
Overarching Aim: to detail the (mechanisms underlying the) actions of GLP-1RA and DPP-4i on the cardiovascular, renal and gastrointestinal system patients with T2DM. For the sake of clarity, we divide the study objectives into 3 parts:Primary…
To determine whether sunitinib rechallenge in patients with mRCC, who had benefit from prior treatment with sunitinib and who progressed on both sunitinib and second-line therapy (or a period of more than 3 months without treatment), can again…
To evaluate the probability that the progression free survival (PFS) in the first-line treatment with RAD001 is non-inferior to the first-line treatment with sunitinib for patients with metastatic renal cell carcinoma (primary objective).…
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 objective: To determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous…
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 select targeted treatment based on ex vivo kinase activity inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for whom no standard treatment is available.
To assess the therapeutic activity of SU11248 in patients with exptensive disease small cell lung cancer who are either chemonaive or have a sensitive relapse
Primary: • To determine the safety and feasibility of PK guided dosing of sunitinib Secondary:• To determine the objective response rate (according RECIST 1.1)• To determine the time to tumor progression and progression free survival• To validate…
Part A:To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeksPart B:• To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of RA at 24…
Primairy objective:To investigate whether the pharmacokinetics of sunitinib are influenced by circadian rhythm.Secondary objective:- to investigate whether daily variation in CYP3A4 activity exists in humans, based on midazolam and 4beta-…
In the proposed study, two main issues will be addressed: first, it will be studied whether a high dose (4.0 mg) of FA supplementation periconceptional has an added value over the now recommended low dose of 0.4 mg in the prevention of congenital…
The primary goal of this research is to develop a pharmacokinetic/pharmacodynamic (PK/PD) model for sunitinib and pazopanib in patients with metastatic renal cell carcinoma, so that the possible use of biomarkers can be tested as predictors for the…
To determine the relation between tumor tissue phosphoproteomic profiles and progression-free survival (PFS) in patients with advanced RCC
Primary objectives:- To determine the maximum tolerated dose (MTD) of sunitinib when administered once a week or once every two weeks.- To assess the safety and tolerability of sunitinib in a once weekly or once every two weeks dose schedule- To…
To evaluate the safety and tolerability of escalating doses of oral sunitinib in combination with standard doses of intravenous ifosfamide in patients with solid malignancies.
To answer the question, if the use of VEGF-R-TKI is associated with psychiatric side effects, and if so, to characterzie their symptomatology.
The aim of the study is:- To find simple clinical and/or laboratory parameters to predict the development of hypertension during treatment with the tyrosine kinase inhibitor Sunitinib. If such parameters are present it will be evaluated…
The objective of the study is to provide access to sunitinib treatment for patients who have completed a prior sunitinib study and are judged by the investigator to have the potential to benefit from sunitinib treatment. During this study the…