34 results
The primary objective is to evaluate the antiviral efficacy of TMC435 in combination with PegIFN*-2a and RBV.In addition to this, the study provides access to TMC435 treatment in combination with PegIFN/RBV to (1) subjects whoparticipated in the…
The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study…
Primary objective: Phase Ib: To estimate the MTD and/or RP2D of BYL719 in combination with cetuximab. Phase II: To compare the efficacy of BYL719 plus cetuximab in comparison with cetuximab monotherapy.Secondary objective (major): safety and…
Primary objectives:• To evaluate the safety and tolerability of BMS-914143 as measured by the frequency of SAEs and discontinuations due to AEs;• To assess the HBeAg seroconversion rate at 24 weeks off treatment (Week 72).Secondary objective• To…
This study aims at developing a novel strategy to optimise the treatment of oesophageal adenocarcinoma and gastro-oesophageal junctional tumors with curative intent. To improve the outcome of patients with this disease we hypothesize that the…
The primary objectives of this study are:* To determine the efficacy of GS-7977 + RBV with or without Peginterferon alfa-2a (PEG) as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (…
RO5479599 is an investigational drug which is investigated by F.Hoffmann-La Roche and the Center for Personalized Cancer Treatment for the treatment of locally advanced or metastatic solid tumors with HER3 overexpression.Substudy BP27771/IMGThe…
Primary objective:• Phase Ib: to assess the feasibility and safety of the addition of cetuximab to methotrexate for recurrent or metastatic SCCHN • Phase II: to assess the efficacy of the addition of cetuximab to methotrexate for recurrent or…
Part IPrimary objectiveTo investigate the pharmacokinetics of the main metabolite of dimethyl fumarate (DMF) - monomethyl fumarate (MMF) - following administration of 3 different controlled release tablet formulations (FP187: V1, V2B, and V3B) and…
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
The main objective of this pilot study is to determine the biological impact of treatment with targeted agents at the systemic and local tissue level in relation to toxicity.
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
Primary:* To determine the efficacy of PSI-7977 in combination with RBV administered for 12 weeks compared with PEG/RBV administered for 24 weeks in treatment-naïve patients with HCV genotype 2 or 3 as assessed by the rate of SVR12 (HCV RNA of…
Primary Objective:The primary objective for this study is to evaluate, in treatment-naive subjects with chronic HCV GT-2 or -3 infection:* SVR12 following 24 weeks of treatment with Lambda/RBV and the SVR12 following 24 weeks of treatment with alfa-…
The main objective of the first part of the study is the demonstration of 89Zr-cetuximab uptake in non-hepatic tumour lesions. The main objective of the second part is the association between 89Zr-cetuximab uptake in non-hepatic tumour lesions and…
The primary aim of this study is to determine the Maximum Tolerated Dose (MTD) of BIBW2992 treatment in combination with cetuximab in patients with Non-Small Cell Lung Cancer with acquired resistance to erlotinib or gefitinib.Safety,…
To determine the toxicity of Zirconium-89 (Zr89) labelled Cetuximab in patient with stage IV cancer.
to study the safety and tolerability of HM10660A (LAPS-interferon alpha-2b), including immunogenicity, as compared to Pegasys® (PEG-interferon alpha-2a)to study the pharmacokinetics and pharmacodynamics of HM10660A (LAPS interferon alpha-2b) as…
To determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine.
1. To determine the safety and tolerability of TMC649128/TMC619688 during multiple dosing in treatmentnaïve and treatment-experienced genotype 1 HCV-infected subjects at different dose regimens as 10-days and 14-days monotherapy.2. To determine the…