109 results
The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the EMA in providing additional safety and efficacy data in approximately 150 patients with Ph+ CML whose disease had failed or who are otherwise not…
The objectives are to determine generic, cancer-generic and prostate cancer-specific HRQOL and costs outside the hospital in CRPC patients during treatment (including best supportive care, docetaxel, cabazitaxel, abiraterone and enzalutamide) in…
The primary objective of the current study is to assess the efficacy of qHPV vaccination in preventing recurrence of high-grade AIN in HIV+ MSM with CD4 counts >350 x 10E6/l who were successfully treated for high-grade intra-anal AIN in the…
Primary Objectives:To explore whether the decrease in a panel of early easily assessable biomarkers (PSA-mRNA, PCA3-mRNA and TMPRSS2:ERG gene fusion-mRNA, (currently under development) ARv7 mRNA, ARwt mRNA, miR-21, miR-141, miR-200a, miRrumc95,…
To provide idelalisib, a marketed PI3K* inhibitor, in lieu of GS-9820, an investigational second generation PI3K* inhibitor, to subjects receiving GS-9820 in Study GS-US-315-0102 at the time of study closure.
This study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer…
To investigate the feasibility and utility of indocyanine green fluorescence imaging for intraoperative perfusion assessment in patients undergoing gastro-intestinal surgery, primarily measured by the number of intraoperative changes in operation…
In this study we want to determine the erlotinib concentrations in blood after administration of erlotinib with water or whole milk with and without an antacid .
The primary objective of the study is to determine the mean prediction error (MPE) and mean absolute prediction error (MAPE) of the area under the plasma concentration-time curve (AUC) of carboplatin after adjusted dosing for high BMI (BMI >…
The main objective of the study is to develop an optimal and individualized asparaginase treatment protocol. The study consist of four sub-studies. The objective of the population pharmacokinetic study is to get more insight in the pharmacokinetics…
Primary ObjectiveTo assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.Secondary Objectives• To estimate…
The primary objective of this study is to provide continued access to vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy who were previously treated in an antecedent vemurafenib protocol and did not meet the protocol*s…
Our primary objective is to study the effect of perioperative intravenous supplementation of omega-3 fatty acids on the perioperative inflammatory response compared to a saline control in patients undergoing surgery for colon cancer.
Objective: The primary goal of the current study is to study the immunogenicity and safety of HPV vaccination in patients with an autoimmune disease. Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune…
Primary objective:To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC). Secondary objectives:To determine if occurrence of docetaxel toxicity can be related to dose/LBM.To…
To determine the influence of the acidic beverage Coca-Cola, concomitantly taken with erlotinib (with or without a PPI), on erlotinib plasma pharmacokinetics compared to erlotinib concomitantly taken with water in cancer patients.
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 explore the effect of Eligard® on the following prostate cancer biomarkers:• Testosterone in serum• Prostate Specific Antigen (PSA) in serum• Prostate Cancer Antigen (PCA3 score) in urine • PSA mRNA in blood/PBMC• PCA3 mRNA in blood/PBMC• TMPRSS2…
To identify what might be the cause of the occurrence of diarrhea during the use of angiogenesis inhibitors sunitinib and sorafenib in patients with a malignancy.
To make an efficacy evaluation of Gadolineum Ethoxybenzyl (Gd-EOB) DTPA-enhanced MR-imaging (Gadoxetic acid, Primovist, Bayer Schering Pharma, Berlin) and Respiratory Triggered Diffusion Weighted Imaging (DWI) for the detection and characterization…