15 results
ObjectivesPrimary objective1. To assess the efficacy of selumetinib in combination with dacarbazine compared with placebo in combination with dacarbazine in terms of Progression Free Survival (PFS) assessed by blinded independent central review (…
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
* to describe the safety profile for qW, q2W and q3W regimens. * to determine the Maximum Tolerated Dose (MTD), if achieved (all regimens)* to describe the pharmacokinetics (PK) of single-agent RO6895882. Substudy BP28920/IMGThe study is designed to…
To assess the efficacy, measured as progression free survival, and safety of Selumetinib in combination with docetaxel, compared to docetaxel alone, in patients receiving second line treatment for KRAS mutation-positive, locally advanced or…
To assess the efficacy, measured as progression free survival, and safety of Selumetinib in combination with docetaxel, compared to docetaxel alone, in patients receiving second line treatment for KRAS mutation negative locally advanced or…
Study questionWhat is the effect of a single administration of prothrombin complex concentrate (CoFact) on the anticoagulant effect of a novel oral thrombin inhibitor (Dabigatran) and a novel oral factor Xa inhibitor (Rivaroxaban) in healthy human…
Objective: The aim of this study is to investigate the in-vivo variability of hemostasis between patients when treated with a direct thrombin inhibitor (Dabigatran) or a direct Factor Xa (FXa) inhibitor (Rivaroxaban) by measuring thrombin generation…
A real world registry to compare dual therapy with Dabigatran/Clopidogrel to Usual care (Triple Therapy) with Dabigatran/Clopidogrel/Aspirin in patients with an indication for NOAC undergoing PCI in the setting of ACS. Hypothesis: Dual therapy with…
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
Primary objectives:Part A: To determine the recommended phase 2 dose and schedule (RP2D) of the selumetinib/afatinib combination in patients with KRASm and PIK3CAwt NSCLC and CRCPart B: To determine the progression free survival (PFS) of the…
The primary objective is to determine whether treatment of acute intermediate-risk PE (as defined by the inclusion and exclusion criteria) with parenteral anticoagulation for at least 72 hours after diagnosis, followed by dabigatran over 6 months,…
To evaluate the safety and efficacy of DOAC versus VKA in CTEPH/CTED patients receiving BPA, based on the composite endpoint of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) and lung injury…
The primary objective is to evaluate whether the impact of a strategy aimed at switching INR-guided VKA management to a NOAC-based treatment strategy is superior in terms of the occurrence of major or clinically relevant non-major bleeding…
Phase IPrimary Objective- To define the recommended phase II dose (RP2D) of selumetinib/dexamethasone combination in adult and paediatric patients with relapsed/refractory, RAS pathway mutant ALLSecondary Objectives- To evaluate safety and…
To measure DOAC levels just before surgery of all DOAC patients in the LUMC with elective surgery for which ceasing of DOAC treatment is required.