116 results
Objectives for Part A1 Monotherapy Dose EscalationPrimary Objective:* To assess safety, and tolerability at increasing dose levels of PF 04518600 in patients with selected advanced or metastatic solid tumors in order to establish the MTD.Secondary…
To determine and compare PK profiles of two of the most used ROOs in cancer patients: one intranasal fentanyl formulation (INFC, Instanyl®) and one sublingual fentanyl formulation (SLF, Abstral®).
The aim of this study is to provide continuing access to BMN 044 treatment for subjects previously treated with the study drug. The information gained from this study is expected to further characterize the efficacy and safety of BMN 044 over a…
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…
Primary ObjectiveThe primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with methotrexate to methotrexate alone in achieving Remission, defined as SDAI less than or equal to 3, at Week 24.…
To evaluate the safety and tolerability of IV administration of SBC-103 in subjects with MPS lllB, Sanfilippo B.
The primary goals of this study are to: i. Identify genetic variations responsible for PLP across the whole genomeMore than 90% of SNPs are found in introns or intergenic regions and most of them are probably of little functional consequence.…
The purpose of this study is to assess the safety, tolerability and efficacy of long term drisapersen in subjects with DMD.
To demonstrate the efficacy of ponatinib administered at 2 starting doses (30 and 15 mg QD) compared to nilotinib administered at 400 mg BID in patients with CP-CML who are resistant to imatinib, as measured by MMR by 12 months
This study will investigate the effect of shear and pressure on tissue viability of human skin. Skin vitality is determined by tissue oxygenation and blood flow, measured with the 'Oxygen to See'. The focus will be on individual response…
The primary objective is:- to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxabanThe secondary objectives are:- to assess the incidence of major bleeding and clinically relevant non-major bleeding- to…
Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…
Period 1:The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with active RA who are on a stable dose of conventional synthetic disease-…
Primary Objective: The aim of this study is to determine the time to all-cause discontinuation of penfluridol (acemap; oral long acting neuroleptic) as compared to second-generation oral neuroleptics (olanzapine, risperidone) using an open label…
Period 1: The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD versus placebo and versus adalimumab for the treatment of signs and symptoms of rheumatoid arthritis in subjects with moderately to severely active RA who are…
Primary objectives:- To evaluate the toxicity and feasibility of a DLI-combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination in B cell hematological malignancies- To evaluate the effect of a DLI-combined minor H ag UTA2-1…
Identify DNA methylation markers suitable for sensitive and specific plasma-based detection of advanced colorectal adenomas.
Primary objective *To determine Maximum Tolerated Dose (MTD) of TH-302 combined with chemoradiotherapy (23 x1.8 Gy in combination with Carboplatinum and Paclitaxel) in patients with distal esophageal or esophago-gastric junction adenocarcinoma, and…
The aim of this study is to explore the efficacy, effectivity and costeffectivity of financial incentives for the promotion of physical activity in the health care setting.
Primary Objective:To assess whether the clinical efficacy of RPC1063 is superior to interferon (IFN) *-1a (Avonex®) inreducing the rate of clinical relapses in patients with RMS.Secondary Objectives:- To assess the effect of RPC1063 on the…