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Effects of a short-term dietary restriction regimen in cancer patients receiving irinotecan.

Primary objective is to demonstrate a 25% reduction of the active irinotecan metabolite, SN38, in healthy liver tissue in patients with mCRC or other solid tumors as a result of preceding dietary restriction five days in advance. Secondary…

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…

Bioavailability of oral ciprofloxacin tablets versus suspension in pediatric cancer patients

To determine the relative bioavailability of ciprofloxacin oral suspension versus oral tablets in pediatric cancer patients, and to determine the absolute bioavailability of tablets and suspension utilizing the 100% bioavailability of intravenous…

Weekly administration of Oral Docetaxel in combination with Ritonavir

To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…

An open-label, individual study groups, fixed sequence, four-period crossover study comparing three proportionate sizes of HP 3020 patch applied for 24 hours with intravenous palonosetron injection (ALOXI®) and a one-period study with one size of HP-3020 patch applied for 168 hours, to investigate the pharmacokinetics, tolerability and safety of HP-3020 patches in healthy male subjects

Primary: To investigate the pharmacokinetics of palonosetron in plasma from three different sizes of HP-3020 transdermal patch applied for 24 hours as compared to intravenous palonosetron (Cohort 1) and to investigate the pharmacokinetics of…

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…

An Open-Label Phase I Study to Assess the Effect of Rifampicin in the Pharmacokinetics of Eribulin Mesylate (E7389) in Subjects with Advanced Solid Tumours

Primary objective• To assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin following intravenous (IV) administrationSecondary objectives• To assess the safety of eribulin when co-…

A pharmacokinetic evaluation of the addition of Aprepitant to the Cisplatin - Etoposide (CE) treatment of patients with metastatic lung carcinoma (ACE)

The question is whether aprepitant should be added to CE cycles (cisplatin containing regimen with etoposide) because of a possible interaction between aprepitant and etoposide.This question derives from the fact that both drugs are metabolised…

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.

The effects of the proton pump inhibitor esomeprazole alone or in combination with Coca-Cola on the absorption of Capecitabine in patients with colorectal cancer or other solid tumours. the COCA study

Primary objective is to evaluate the area under the plasma concentration-time curve (AUC) of capecitabine alone, compared to capecitabine used with esomeprazole and compared to capacitabine used with esomeprazole and the acid beverage Coca-Cola in…