83 results
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…
* 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 explore the safety, tolerability and the pharmacokinetic profile of 2-IB when given on top of therapeutic hypothermia.
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…
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…
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…
to confirm that GMC 252 is absorbed in humansto determine in humans whether GMC 252 is cleaved, yielding diflunisal and N-acetylcysteine (NAC)to determine whether additional metabolites are formed with GMC-252 compared with diflunisal and NAC
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
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
The objectives of this study are to examine: (1) the long-term safety and efficacy of alemtuzumab in multiple sclerosis (MS) patients who received alemtuzumab during prior Genzyme-sponsored studies including CAMMS223, CAMMS323, or CAMMS32400507 (…
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…
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…
The purpose of the study is to investigate whether the cyclodextrin added to the cholecalciferol formulation has an effect on the vitamin D3 availability in the body. Thus, it will be investigated if concentrations of vitamin D3 that are found 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 longterm safety and tolerability of oral BAY 63-2521 in patients…
The objectives of this study are to compare the safety and efficacy of 2 annual cycles of intravenous (IV) alemtuzumab to 3-times weekly subcutaneous (SC) interferon beta 1a (Rebif*) in patients with active relapsing-remitting multiple sclerosis (…
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.…