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Effects of aprepitant (Emend ®) on the pharmacokinetics of fentanyl.

Primary Objective: - to study the influence of administration aprepitant (Emend ®) on the clearance of fentanyl, in patients using a stable dose of the fentanyl patch (Durogesic ®).Stable dose is defined as using the same dose of fentanyl during at…

153Sm-EDTMP versus docetaxel for multiple painful osseous metastases in prostate cancer

The sequential application of chemotherapy and radionuclide treatment in patients with symptomatic osseous metastasized prostate cancer. Patients with more than one painful osseous metastasis will be randomized between 153Sm-EDTMP or docetaxel 3…

A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

Primary: To demonstrate the superior efficacy of Nasalfent in the treatment of BTCP in opioid tolerant subjects who are receiving regular opioid therapy.Secondary: To demonstrate the safety, tolerability, and acceptability of Nasalfent in the…

Administration of immune checkpoint inhibitors through an elastomeric pump. A patient preference study and cost analysis.

The primary objective of this study is to evaluate the patient preference for either ICI-B or ICI-P. Secondary objectives are: to assess patient satisfaction with ICI-B and ICI-P, to establish the safety of ICI-B and ICI-P to establish the…

A single-center, randomized, open-label, two cohort, two-period crossover study to investigate the bioequivalence of alpelisib optimized final market image formulation (FMIopt) and the final market image (FMI) tablet formulation in healthy volunteers in the fasted and fed state

The purpose of the study is to investigate how quickly and to what extent 2 different production batches of alpelisib (FMI and FMIopt) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…

An open-label cross-over proof of concept study to investigate the intratumoral pharmacokinetics of CriPec® docetaxel versus Taxotere® (the CRITAX study)

To demonstrate a 25% increase of docetaxel in tumor tissue after intravenous with CriPec® docetaxel compared to Taxotere®. Additionally, systemic PK profile and adverse events will also be evaluated.