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MAL-PDT of superficial basal cell carcinoma using two light fractions with one or two hours interval: comparison of illumination at 3 and 4 hours with illumination at 3 and 5 hours after application of MAL

The aim of the present study is to study Metvix® photodynamic therapy (MAL-PDT) of superficial basal cell carcinoma (sBCC) using two light fractions with one or two hours interval: comparison of illumination at 3 (20 J/cm2) and 4 hours (55 J/cm2)…

Rituximab in Primary Central Nervous system Lymphoma.
A randomized HOVON / ALLG intergroup study

Primary objectiveTo assess the effect of the addition of rituximab in a standard chemotherapy regime on EFS in newly diagnosed PCNSL.Secondary objectiveTo evaluate the effect of the addition of rituximab to a standard chemotherapy regimen with…

Oncolytic adenovirus therapy as an adjuvant treatment for localised prostate cancer.

The main objective is to evaluate the safety and tolerability of Ad[I/PPT-E1A] as an adjuvant treatment for localised prostate cancer before radical prostatectomy. A secondary objective is to explore the histopathological and immunological effects…

A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS

* To assess maintenance of biochemical control of octreotide capsules compared to parenteral SRLs in patients with acromegaly, who previouslydemonstrated biochemical control on both treatments.* To assess symptomatic response to octreotide capsules…

Adjuvant peginterferon alfa-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group.

To prospectively assess the efficacy, toxicity, quality of life with peginterferon alfa-2b as compared to observation after adequate surgery for ulcerated primary cutaneous melanomas with T(2-4)bN0M0

A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.

Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…

The effect of curcumin and piperine on the pharmacokinetics of tamoxifen in patients with breast cancer *the ELDORADO study*

The main objective is: To determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).Secundary objectives are:1. Other pharmacokinetic outcomes (i.e. clearance, minimum…

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…

A Phase 2 Study of LY2606368 in Patients with Extensive Stage Disease Small Cell Lung Cancer

Primary:Cohort 1: To estimate the ORR when a dose of105 mg/m2 LY2606368 every 14 days isadministered to patients with ED-SCLC that haveplatinum-sensitive disease* Cohort 2: To estimate the ORR when a dose of105 mg/m2 LY2606368 every 14 days…

A phase II trial of TTFields in addition to pemetrexed and cisplatin or carboplatin as first-line
treatment in malignant pleural mesothelioma

Primary Objective:* To determine if TTFields in combination with pemetrexed/platinum improves overall survival (OS) compared to historical control in patients with unresectable mesothelioma.Secondary Objectives:* To evaluate the overall response…

Combination of salvage surgery and adjuvant photodynamic therapy in management of recurrent or residual sinonasal tumors.

The main objective of this study is to develop a PDT and salvage surgery combination specific for recurrent or residual tumors of the sinonasal cavities, unsuitable for the conventional treatments like radical surgery or radiotherapy with curative…

MOSAIC-2 Study: MOdel to Study upper Airway Immunity upon Cholera vaccination

To investigate whether raw milk, pasteurized milk or ultra-heat treated (UHT) milk is able to enhance the systemic immune response as induced by oral cholera vaccination, in comparison to regular vaccination. Oral vaccination can also induce an…

Cognitive outcome after Gamma Knife Radiosurgery in patients with brain metastases

Primary Objective Our primary aim is to evaluate the course of cognitive functioning (stability, impairment or decline, or improvement as compared to Dutch controls) after usual care SRS in patients with 1-10 BM at time of treatment initiation.…

Phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by pazopanib versus pazopanib followed by sorafenib in the treatment of advanced / metastatic renal cell carcinoma

Primary:To evaluate if progression-free survival from randomization to progression or death during second-line therapy (total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib.Secondary:1. Time from…

LUME-Meso: Double blind, randomised, multicentre, phase II/III study of nintedanib in combination with pemetrexed / cisplatin followed by continuing nintedanib monotherapy versus placebo in combination with pemetrexed / cisplatin followed by continuing placebo monotherapy for the treatment of patients with unresectable malignant pleural mesothelioma

To evaluate the safety and efficacy in terms of progression-free survival (PFS) and overall survival (OS) of nintedanib + pemetrexed / cisplatin followed by nintedanib versus placebo + pemetrexed / cisplatin followed by placebo as first line…

A Phase 1 Pharmacokinetic-Pharmacodynamic Study of Avelumab (MSB00100718C) in Patients with Previously Treated Advanced Stage Classical Hodgkin*s Lymphoma

Primary Objective* To characterize the pharmacokinetics (PK) of different dosing regimens of avelumab and its relation to target occupancy (TO) in peripheral blood of patients with classical Hodgkin*s Lymphoma (cHL).Secondary Objectives* To evaluate…

Influence of a fatty beverage (Milk) on the absorption of erlotinib: a randomized, cross-over pharmacokinetic study (MERLOT-study)

In this study we want to determine the erlotinib concentrations in blood after administration of erlotinib with water or whole milk with and without an antacid .

The effects of the proton pump inhibitor esomeprazole on the bioavailability of regorafenib in patients with a metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumour (GIST).

To determine the influence of esomeprazole on the AUC of regorafenib in patients with mCRC or GIST.

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-DOSE ESCALATION, MULTIPLE-DOSE ESCALATION, AND FOOD EFFECT STUDY OF FLX475 IN HEALTHY MALE AND FEMALE SUBJECTS

The purpose of this study is to investigate how safe the new compound FLX475 is when it is administered to healthy subjects. FLX475 has not been administered to humans before. It has been previously tested in the laboratory and on animals. FLX475…

A Phase 1 Dose Escalation and Phase 2 Randomized Double-Blind Study of Veliparib in Combination with Carboplatin and Etoposide as a Therapy of Treatment-Naïve Extensive Stage Disease Small Cell Lung Cancer.

The objectives of the Phase 1 dose escalation are:Primary Objectives:* To establish the Maximum Tolerated Dose (MTD) and to establish the Recommended Phase 2 Dose (RPTD) for veliparib in combination withcarboplatin and etoposide.* To evaluate the…