135 results
Compare efficacy and safety ofpomalidomide versus placebo in reversing RBC-transfusiondependence in subjects with MPN-associated myelofibrosis and RBC-transfusion-dependence. Investigate variables correlated with RBC-transfusion-independence and/or…
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)…
Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this phase III study is to compare treatment with bortezomib/dexamethasone + panobinostat to bortezomib/dexamethasone +…
Estimate the maximum tolerated dose (MTD) of AEB071 (dose escalation) and characterize the safety and tolerability of the MTD or recommended Phase 2 dose of AEB071 in patients with DLBCL (dose expansion).
Evaluation of intensive therapy for relapsed B-cell lymphoma with CNS localisation. Treatment includes:a. intrathecal administration of rituximab, B. combining R-DHAP with high dose methotrexate intravenously.The following endpoints will be…
To assess sorafenib pharmacokinetics and biodistribution, K-Ras mutational status, tumor uptake and tumor response in NSCLC patients.
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability and pharmacokinetics of midostaurin in children <18 years of age and >= 3 months who have relapsed or refractory leukemias that may benefit…
The primary objective of the study is evaluating the safety, tolerance and anti-lymphoma activity of the anti-CD79b-MMAE conjugate (DCDS4501A) and the anti-CD22-MMAE conjugate (DCDT2980S), both given in combination with Rituximab once every 4 weeks…
Primary:* To evalaute the efficacy of three doses of norUDCA vs. placebo for the treatment of PSC* To identify efficacious norUDCA dose(s) for the treatment of PSC for further evaluation in phase III. Secondary:* To study safety and tolerability (…
Primary ObjectivesTo quantify BCT197, and to identify and quantify its metabolites in plasma, urine, and feces.To determine the pharmacokinetics of total 14C-radioactivity in blood and plasma, and of any important metabolites in plasma and excreta.…
The primary objective of this study is to : Assess the hemodynamic profile of Riociguat in patients with symptomatic pulmonary hypertension associated with left ventricular systolic dysfunction The secondary objectives of this study are to : -…
As results from a recently completed radio-labeled human ADME study [CLBH589B2108] in patients indicated that both kidney and liver are involved in the elimination and metabolism of panobinostat, understanding the impact of altered organ function…
To assess the bioequivalence of 6 mg dexamethasone tablet administered PO as an alternative to 5,26 mg dexamethasone-disodiumphosphate (= 4 mg dexamethasone) solution administered IV
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…
To compare the combination treatment of everolimus and exemestane to exemestane alone with respect to progression-free survival in postmenopausal women with estrogen receptor positive breast cancer that is refractory to non-steroidal aromatase…
BAY 63 2521 is a direct stimulator of the soluble Guanylate Cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially Pulmonary Hypertension (PH).To assess the efficacy and safety of oral BAY 63 2521 in the treatment of…
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 objective:Phase 1b:-To evaluate the safety and tolerability of escalating doses of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer.Phase 2:-To evaluate the efficacy of mapatumumab…
Primary objective: To determine if apixaban is noninferior to warfarin (INR target range 2.0-3.0) in the combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in subjects with AF and at lease one additional risk factor for…
Primary Objective1. The main objective of this study is to demonstrate that OM/AML/HCTZ triple combinations are more efficacious in lowering SeDBP than corresponding dual combinations of OM/AML after 10 weeks of double blind treatment.Secondary…