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Vaccination with minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation (a phase I study)

The primary objectives of our study are to evaluate safety, toxicity and capability of inducing T cell responses of vaccination with, monocyte-derived donor DC electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had…

Effect of body mass index (BMI) and cigarette smoking on the pharmacokinetics of fentanyl

Primary Objective: to study the influence of a BMI < 20 or a BMI > 25 on the clearance of fentanyl, in patients using a stable dose of the fentanyl patch (Durogesic ®).to study the effects of smoking on the clearance of fentanyl, in…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks (Q3W) in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy.

The purpose of this study is to evaluate the safety of darbepoetin alfa, inclusive of the effects on survival and cancer progression, and the necessity of blood transfusions.

Stereotactic body radiotherapy for cT1c - cT3a prostate cancer with a low risk of nodal metastases (<= 20%, Roach index): a Novalis Circle Phase II prospective randomized Trial*

Aim of this study is to investigate the tolerance and the outcome of extreme hypofractionated RT for prostate cancer by delivering a high dose using two alternative time schedules, a short and long treatment interval.

A multi-center, open-label study to assess pharmacokinetics of TKI258 in adult cancer patients with normal and impaired hepatic function

To evaluate the effects of mild, moderate or severe hepatic impairment versus normal hepatic function on the pharmacokinetics of TKI258 in patients with advanced solid tumor

Early recognition and optimal treatment of delirium in patients with advanced cancer

In this study, we aim to improve recognition of delirium in a palliative care population with advancedcancer and we aim to provide evidence for optimal treatment of delirium through adequate dosing ofpreferred neuroleptic.Primary objectives:1) To…

Phase Ib trial of the combination of PI3K inhibitor BAY 80-6946 and allosteric-MEK inhibitor BAY 86-9766 in subjects with advanced cancer

The purpose of this study is to find the answers to the following research questions:1. What are the side effects of the combination of BAY 80-6946 and BAY 86-9766 when given together at different dose levels?2. What dose level of BAY 80-6946 and…

Evaluation of the effect of psycho-oncological intervention on well-being of patients with advanced prostate cancer on LHRH analogs and their partners.
A randomized controlled pilot study.

To asses the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on well-being of patients on LHRH analogs in the treatment of prostate cancer and their partners.

PSCT19 Vaccination with PD-L1/L2-silenced minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation (a phase I/II study)

The primary objectives of our study are to evaluate safety, toxicity and capability of inducing T cell responses of vaccination with, monocyte-derived donor DC transfected with PD-L1/L2 siRNA and electroporated with mRNA encoding hematopoietic-…

A Phase 1 Study of Combination Therapy with SAR405838 and Pimasertib in Patients with Advanced Cancer

The main purpose of the study is to evaluate the safety and tolerability (any toxicities and side effects) of SAR405838 and Pimasertib and that includes identifying the maximum safe and tolerable dose of the study drugs. Also to assess the anti-…

The effectiveness of a tailored intervention program on return-to-work in unemployed sick-listed cancer patients and survivors: A randomized controlled trial.

To evaluate the effectiveness of a tailored intervention program for unemployed sick-listed cancer patients and survivors on return-to-work, compared to care as usual.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Single Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Effect of Food on Pharmacokinetics of CAL-120 in Healthy Male Subjects

Primary:to evaluate the safety and tolerability of single dose administration of the study drug in healthy male subjectsto determine the pharmacokinetic parameters following single dose administration of the study drug in healthy male subjectso…

MR-guided focal laser ablation of the prostate: a pilot study

Main objective of this study is to test the feasibility and to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer. Secondary…

Assessment of tumor hypoxia during radiotherapy course in locally advanced Head and Neck cancer with 18F-fluoroazomycin arabinoside (18F-FAZA)-PET-CT

To investigate for patients with locally advanced HNSCC, the dynamics of tumour hypoxia during the course of radiotherapy/chemoradiation using 18F-FAZA PET-CT. To investigate the best strategy for gradual dose escalation. This may be done by using…

An open-label, multicenter phase II study to compare the efficacy and safety of RAD001 as first-line followed by second-line sunitinib versus sunitinib as first-line followed by second-line RAD001 in the treatment of patients with metastatic renal cell carcinoma

To evaluate the probability that the progression free survival (PFS) in the first-line treatment with RAD001 is non-inferior to the first-line treatment with sunitinib for patients with metastatic renal cell carcinoma (primary objective).…

A randomized, double-blind placebo- and active-controlled study of the pharmacokinetics, pharmacodynamics and safety of single ascending doses of HM10660A (LAPS-Interferon Alpha-2B) in healthy male subjects

to study the safety and tolerability of HM10660A (LAPS-interferon alpha-2b), including immunogenicity, as compared to Pegasys® (PEG-interferon alpha-2a)to study the pharmacokinetics and pharmacodynamics of HM10660A (LAPS interferon alpha-2b) as…

A Phase Ib/randomized phase II study of BEZ235 and trastuzumab versus lapatinib and capecitabine in patients with HER2-positive locally advanced or metastatic breast cancer who failed prior to trastuzumab.

PrimairTo determine the MTD and/or RP2D of oral twice daily (BID) BEZ235 in combination with trastuzumab in patients with HER2-positive breast cancerSecondairTo assess the preliminary activity of the combinationTo assess the safety and tolerability…

OPEN LABEL PHASE I STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF RIFAMPICIN ON THE SINGLE-DOSE PHARMACOKINETICS OF TASQUINIMOD IN HEALTHY SUBJECTS

Primary : To assess the effect of multiple doses of rifampicin on the single-dose pharmacokinetics (PK) of tasquinimodSecondary : To assess the safety and tolerability of multiple doses of rifampicin with a single dose of tasquinimod

A phase Ib/II study investigating the combination of RAD001 with trastuzumab and paclitaxel in patients with HER2-overexpressing metastatic breast cancer.

To evaluate the efficacy of the dose level/regimen(s) of RAD001recommended from the phase I with HT therapy. This will bebased on the evaluation of overall response rate according toRECIST [Post-Text Supplement 1].

OPEN LABEL PHASE I STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF KETOCONAZOLE ON THE SINGLE-DOSE PHARMACOKINETICS OF TASQUINIMOD IN HEALTHY SUBJECTS

Primary:- To assess the effect of multiple doses of ketoconazole on the single-dose pharmacokinetics (PK) of tasquinimod.Secondary:- To assess the safety and tolerability of multiple doses of ketoconazole with single doses of tasquinimod.