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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…

Xerostomia after submandibular gland sparing radiotherapy

The objective of this study is to determine the prevalence of xerostomia after radiotherapy of oropharyngeal tumors when sparing the parotid glands and one submandibular gland.

A Phase I Study of Oral Topotecan in Subjects with Cancer and
Impaired Renal Function

Primary• To determine the safety profile of oral topotecan in subjects with cancer andmildly moderately or severely impaired renal function (Groups C, D and E) compared to subjects with cancerwhose renal function is normal and who have received…

Efficacy of a course "Living with head and neck cancer" in patients with head and neck cancer and their spouses

To obtain insight in the usefulness and efficacy of psychosocial intervention for HNC patients and their spouses by performing a pilot study.

An early clinical feasibility study of a new prosthesis: the NewBreez® Intralaryngeal device; a possible solution for severe aspiration in head and neck cancer patients

This is a feasibility study to assess this new device after 6 months use. There are 3 objectives that have to be fulfilled in order use this device in the future:1. Safety of the NewBreez® at 6 months: has there been further damage done to the…

Phase-2 clinical trial on the treatment of chronic dysphagia in head and neck cancer patients with dedicated strengthening exercises using the Swallow Exercise Aid

Primary objective: effectiveness of the SEA exercises in HNC patients with chronic dysphagia, following an exercise protocol of 6 weeks.Secondary objective: feasibility/compliance of the SEA exercises in HNC patients with chronic dysphagia, during…

First-in-human phase I safety, pharmacokinetic, and pharmacodynamic study of G1T28-1 in healthy male and female subjects.

The purpose of the study is to investigate to what extent G1T28-1 is tolerated. It will also be investigated how quickly and to what extent G1T28-1 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, a possible…

Venlafaxine for prevention of oxaliplatin-induced peripheral neuropathy - A randomised clinical trial

Given the significant number of patients with OIPN and the possible prophylactic properties of venlafaxine, this study is designed. This study will consist of a randomised placebo-controlled clinical trial to study the prophylactic effect of…

Lymphatic mapping of the neck in oral cavity malignancies using ICG-nanocolloid

Primary aim:Lymphatic mapping of the neck in oral cavity malignancies using ICG-nanocolloid. Secondary aims:- Analysis of lymphatic drainage of the head and neck area to determine the extension of the neck dissection.- Identification of the tumor…

A RANDOMIZED, SINGLE DOSE, DOUBLE BLIND, PARALLEL GROUP, PHARMACOKINETIC TRIAL, COMPARING ONS-1045 (ONCOBIOLOGICS INC, USA) TO 2 ARMS OF AVASTIN® (GENENTECH, SOUTH SAN FRANCISCO, USA; ROCHE, SWITZERLAND) IN HEALTHY MALE VOLUNTEERS

Primary Objective:To demonstrate pharmacokinetic biosimilarity of ONS-1045 (Oncobiologics) to the EU- and US licensed product of Avastin® following a single 2.0 mg/kg i.v. infusion, in healthy male adult subjects.Secondary objective:• To evaluate…

A phase 1 randomized, double-blind, placebo-controlled, maximum tolerated dose escalation, safety, tolerability and pharmacokinetic adaptive study of RAD1901 administered to healthy postmenopausal women

The purpose of the study is to investigate to what extent RAD1901 is tolerated.It will also be investigated how quickly and to what extent RAD1901 is absorbed and eliminated from the body.In addition, in Group 6 it will be investigated to what…

A multicenter, open label, phase 1 dose escalation study to evaluate the pharmacokinetics, safety, and tolerability of INC280 tablet formulation with food in patients with cMET dysregulated advanced solid tumors

Primary: 1/ To determine the higher of the tolerated dose of INC280 tablets with food between 300 and 400 mg BID in patients with cMET dysregulated advanced solid tumors. 2/ To assess the PK of INC280 with food.Secondary: To assess the safety of…

A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HBM4003 in Subjects with Advanced Solid Tumors

Part 1: Dose-Escalation Stage (not in The Netherlands)Primary objective:* Safety and tolerability of HBM4003Secondary objectives:* Preliminary anti-tumor activities of HBM4003 in advanced solid tumors* Pharmacokinetics (PK) of HBM4003Other…

An open label, dose escalation followed by dose expansion, safety and tolerability trial of CAN04, a fully humanized monoclonal antibody against IL1RAP, in subjects with solid malignant tumors.

Primary ObjectivesPart I- To define the Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D) of CAN04 once weekly (Q1W) in subjects with relapsed or refractory NSCLC, PDAC, TNBC or CRC.Part II- To determine the safety and tolerability of…

A clinical phase I, open-label PET study with 89Zr CriPec docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of 89 Zr CriPec docetaxel

The primary objectives of this study is to determine whether uptake of 89Zr CriPec® docetaxel in tumour lesions can be detected and quantified

Indocyanine green dye in surgical treatment of laryngeal cancer: perfusion assessment to identify patients at risk for complications

Primary Objective: We want to estimate cut off values for clinically appropriate hypoperfusion of the pharyngeal mucosa and the skin in the neck. Secondary Objective: We want to compare perfusion rate of PTL to perfusion rate in STL in order to…

The UMBRELLA Study - MRI protocol development for MRI for MR-guided radiotherapy on the MR-Linac

Goal of the UMBRELLA Study is the optimization of existing MRI protocols and processing techniques required for MRI guided radiation treatment on the Marlin system (MRI of the MR-Linac) and diagnostic MRI scanners in the radiology department needed…

The Effect of Enzalutamide on Oxycodone Metabolism in Men with Prostate Cancer

To investigate the effect of enzalutamide on the pharmacokinetics (PK) of oxycodone following a single 15 mg oral dose of normal-release oxycodone in men with prostate cancer.

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator*s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

The purpose of this study is to demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in participants with second- or third-line (2L-3L) cervical cancer (Overall Survival-OS)

AMC colorectal organoids biobank: a living biobank

The aim of this proposal is to test this concept using organoid cultures and biobanked material of colon cancer patients and use these cultures to develop novel therapies in particular for the CMS4 subtype, which has mesenchymal features, a dismal…