82 results
* 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 compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
Earlier research nas shown the emerging efficacy and safety profile for INC424, which supports further studies in PV subjects who demonstrate resistance or intolerance to HU therapy [Barosi et al.2009]. This pivotal phase III trial (CINC424B2301) is…
1.To monitor the safety and tolerability of racecadotril in combination with 111In-DOTA-MG112.To study in patients whether the neutral endopeptidase (NEP) inhibitor racecadotril improves the in vivo stability of the radiopeptide 111In-DOTA-MG11
The primary objective of the study is to ascertain the feasibility and safety to image tumor angiogenesis in head- and neck cancer patients using Ga-68-DOTA-RGD2 PET/CT. Secondary objectives are to determine the pharmacokinetics and biodistribution…
PrimaryTo determine whether the palatability of a newly developed formulation of valacyclovir is non-inferior to administration of crushed and suspended tablets in children, is the primary objective of the second phase of the trial.The primary…
The main purpose of this study is to assess whether the study drug anetumab ravtansine is more effective than treatment with vinorelbine in patients with stage IV, mesothelin overexpressing malignant pleural mesothelioma. Efficacy will be measured…
To explore the safety, tolerability and the pharmacokinetic profile of 2-IB when given on top of therapeutic hypothermia.
Quizartinib selectively inhibits survival pathways that block apoptosis by inhibiting FLT3. Quizartinib inhibits proliferation of FLT3-dependent cell lines, and is effective in human leukemia tumor xenograft models of AML. Data from the Phase 1 and…
The objective is to study the feasibility of different PET tracers to detect vulnerable plaques in patients with a recent acute coronary syndrome and co-localize these inflammatory lesions with anatomical plaque features obtained with CT based…
The primary objective of this study will be to determine the pharmacokinetic profile of lorazepam oral liquid 1 mg/ml in the paediatric ICU population, with specific attention for the population aged up to 12 years of age.The secondary objectives…
The primary objective of this study is to measure whether αvβ3 integrin expression and tracer uptake values of 68Ga-DOTA-(RGD)2 change in patients with (recurrent) low-flow vascular malformations after embolization therapy.
CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
Pertuzumab is an investigational agent being studied for the treatment of HER2-positive gastric cancer. This study intends to provide a dose of pertuzumab to find an acceptable minimum pertuzumabconcentratie pertuzumab effective when administered in…
BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the long-term safety and tolerability of BAY 63 2521 in the treatment…
Primary:To assess the effect of various degrees of impairment in hepatic function as measured by NCICTEPcriteria, on the pharmacokinetics of panobinostat.Secondary:To assess the effect of various degrees of hepatic functions on the safety of…
The study the influence of two different inhalationflow manoeuvres on the lungdeposition in patients with cystic fibrosis categorized to patientgroups varying in FEV1 longfunction value and age.
The objective is to study the effect of beta-agonist and beta-antagonist treatment on human bone remodeling.
The primary objective is:To evaluate the efficacy of pomalidomide (CC-4047) monotherapy in subjects with refractory orrelapsed and refractory multiple myeloma who discontinued treatment after being treated withdexamethasone alone (Treatment Arm B)…