33 results
Primary objective:To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.Secondary objectives:To determine the ratio of the…
To evaluate in detail the functionality of immune cells in the liver and blood in chronic HCV patients before, during and after treatment with telaprevir, pegylated-IFN-alfa and ribavirin.
OBJECTIVES AND HYPOTHESISPrimary ObjectivesThe primary objectives are to determine- the effect of steady-state telaprevir 750 mg every 8 hours (q8h) on the multiple dose pharmacokinetics ofphenytoin 200 mg every 12 hours (q12h) in healthy subjects,…
Primary: To provide metastatic colorectal cancer patients with access to aflibercept and todocument the overall safety in these patientsSecondary: To document the Health-Related Quality of Life of aflibercept in this patientpopulation
Primary Objective• For Arms A, B, and C: Determine the overall response rate (RR) of EZN-2208 for two distinct cohorts of patients with mCRC- Patients with mutated K-RAS tumors (Arm A)- Patients with wild-type K-RAS tumors (Arms B and C)• For Arms B…
Primary:To estimate the difference in SVR rates between T12/PR24 and T12/PR48 treatment regimens in subjects who achieve eRVR.Secondary:To evaluate the safety of telaprevir in combination with Peg-IFN-alfa-2a and RBV in treatment-naïve subjects with…
This study involves research and the objective of this study is to investigate the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug moves through the body) of telaprevir. And to obtain additional data regarding the safety…
The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…
The objectives are:- to provide access to telaprevir for subjects with chronic HCV genotype 1 infection who wererandomized to the control group in the C216 trial and who failed therapy for virologicreasons;- to evaluate efficacy, safety, and…
To compare to control (Group A) (peginterferon alfa-2a [Peg IFN-*-2a] and ribavirin [RBV] for 48 weeks) the proportion of subjects who achieve sustained viral response (SVR, undetectable HCV RNA 24 weeks after completion of treatment) when given…
The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…
To provide access to a telaprevir-based treatment to subjects of the Control Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate response to treatment (according to treatment stopping rules). Safety, tolerability, and HCV…
The first aim of the study is to investigate the effect of telaprevir on the concentration of LPV/rtv and ATV/rtv in the blood and the effect of LPV/rtv and of ATV/rtv the concentration of telaprevir in the blood.The second aim is to investigate the…
Phase A:Primary objective: Determining the feasibility of gemcitabine as a radiosensitizer in DIPG Secondary objective: Evaluation of efficacy in terms of clinical and radiological response rate and progression free survivalTertiary objectives:…
To find the maximum tolerated dose of glass yttrium-90 (90Y) microspheres (TheraSphere®), when combined with DEBIRI in patients with liver-dominant colorectal liver metastases (CRLM).
This protocol is designed to determine the safety, tolerability, and efficacy of SGI-110 in combination with irinotecan in previously treated patients with metastatic colorectal cancer who progressed on irinotecan.
Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…
To develop a dosing nomogram of irinotecan in patients homozygous polymorphic for UGT1A1*28 and/or UGT1A1*93 in order to reduce the incidence of severe irinotecan-associated toxicity, defined as febrile neutropenia during the first two cycle of…
Primary:1) To compare OS in subjects with squamous cell carcinoma of the Esophagus.2) To compare OS in subjects with PD-L1 Combined Positive Score (CPS)*10%3) To compare OS in all subjectsSecondary:1) To evaluate the progression free survival (PFS)…
- Primary Objective:To evaluate the safety and tolerability of investigational regimens of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors- Secondary Objectives:To characterize PK of product(s) used in investigational…