27 results
Primary objectives:To confirm the lack of effect of 0.5 mg sublingual testosterone on physiological and subjective measures of sexual arousal in women with HSDD. Secondary objective:To confirm the lack of effect of 0.5 mg sublingual testosterone on…
Primary objectives:To establish the lowest effective dose using physiological and subjective measures of sexual arousal.To evaluate and compare the pharmacokinetics of testosterone and its metabolites following administration of three (3) doses (0.…
Primary objectives:- To improve the clinical effectiveness of the p53 synthetic long peptides vaccine by pre-administration of cyclophosphamide.- To evaluate the immunogenicity of a p53 synthetic long peptide vaccine when preceded by administration…
We estimate that the anthracycline and cyclophosphamide dose could be significantly (>=15%) increased in at least 15% of ACC-treated patients. Therefore, in order to diminish the risk of under-dosing ACC, we aim to develop a neutrophil-guided…
To determine a safe dose combination of carboplatin-cyclophosphamide combined with atezolizumab fixed dose in advanced breast cancer and gynaecologic cancer (ovarian, cervical and endometrial cancer).
To compare the pharmacokinetics of sublingual testosterone cyclodextrin followed by buspirone as an encapsulated tablet with administration of testosterone and buspirone as one tablet designed to release the components in a specific time-frame.
This study will investigate whether oligometastatic triple negative or BRCA1/2 related breast cancer can be treated effectively with a multimodality approach including induction chemotherapy, and whether high dose alkylating chemotherapy can improve…
Primary objective:To compare the pharmacokinetics of testosterone and sildenafil citrate following administration of a sublingual solution of testosterone with an encapsulated tablet versus a combination product.Secondary objective:To investigate…
Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…
Primary ObjectiveTo investigate the possible efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with…
The primary objective of the trial is to evaluate whether L-BLP25 administered as weekly subcutaneous vaccinations with or without pretreatment with intravenous cyclophosphamide (CPA) induces a change in immune response parameters (ELISpot against…
To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of nelarabine, etoposide and cyclophosphamide when given in combination to children with T-ALL and bone marrow relapse or T-LL.
We expect to finalize the current phase I study by the May 2008 demonstrating that injection of tumor lysate-pulsed autologous DCs injected in patients with MM after chemotherapy is safe and well tolerated with induction of immune responses. New…
The overall aim of the CASA trial is to investigate the role of PLD as adjuvantchemotherapy for older postmenopausal women for whom chemotherapy is indicated, but standard regimens, derived from trials in younger women, are assumed to be too toxic…
Nearly all patients who die from breast cancer die from the consequences of distant metastases. Adjuvant chemotherapy, either administered before or after surgery, has been shown to reduce the risk of metastases and death. Four main groups of…
The main goal of neoadjuvant therapy should be a pathological complete response (pCR), because pCR more accurately predicts improved patient outcome and prolonged survival. In the present study, pathological response will be evaluated by The Miller…
During the course of the study 2 randomisation questions will be adressed. Both questions concern patients in the high risk group.Randomisation question 1: Will the addition of Doxorubicin to the first 4 standard IVA chemotherapy courses lead to a…
- To evaluate the treatment efficiency by time to progression according to RECIST 1.1
Primary objective1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulationSecondary objective1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed…
Primary objective1. To determine the effect of food on the pharmacokinetics of sildenafil administered as the Lybrido formulation2. To determine whether >90% of the testosterone content is released after maximally 90 seconds after sublingual…