84 results
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 (…
* 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 the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for GA at birth while confirming the dose of rhIGF 1/rhIGFBP-3 is safe and efficacious.
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 to assess the effect of missed doses of atomoxetine and OROS methylphenidate in ADHD patients who are stable on pharmacotherapy based on the patient*s daily behavior as assessed by the Daily Parent Report of…
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…
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 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)…
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
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
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…
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…
Primary Objective: * To confirm the safety profile of plerixafor to mobilise stem cells when used in patients with lymphoma or MM who are eligible to undergo treatment with an autologous haematopoietic stem cell transplantSecondary Objectives:* To…
Primary: To assess the antiviral efficacy of triple combination antiviral drug (TCAD) therapy(i.e. amantadine and ribavirin co-administered with oseltamivir) compared to oseltamivirmonotherapy in immunocompromised subjects diagnosed with Influenza…
The primary objective of this study is to determine the excretion balance and to elucidate the metabolic pathway of eribulin in vivo after a single dose of carbon-14 radio-labeled eribulin (14C-eribulin), inpatients with advanced solid tumors.
Primary objective• To assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin following intravenous (IV) administrationSecondary objectives• To assess the safety of eribulin when co-…
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.