28 results
The primary objective of this study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism and excretion) of docetaxel (as ModraDoc003 10mg tablets) after administration of a single dose of oral docetaxel in…
- evaluation of the safety of extended use of ModraDoc006/r - provide longterm access to ModraDoc006/r treatment for patients who have completed a phase I trial with ModraDoc006/r and who might have benefit from longterm treatment with weekly…
To suppress low-level viremia to a level below 50cp/mL in patients using cART by switching their current non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI to DRV boosted with ritonavir (RTV) (DRV/r). Secondary objectives are to reduce the…
To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…
Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…
Primary Objective: To assess the effect of multiple oral doses of atazanavir 300 mg + ritonavir 100 mg once daily on the PK of BMS-790052 at steady state in healthy subjects.Secondary Objective(s): To assess the safety of multiple oral doses of BMS-…
The primary objectives are:* to determine the effect of steady-state concentrations of TMC114 coadministered with a lowdose of ritonavir on the steady-state pharmacokinetics of ddI,* to determine the effect of steady-state concentrations of ddI on…
Objective of the studyThe present pilot study will be focused to define the sensitivity of SRS in MM patients and in patients with plasmacytoma. This in comparison to X-ray examination. In addition it will be investigated whether SRS can be used as…
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers
Primary Objectives:• To assess the effects of VOR 200 mg BID on the steady-state PK of ATV administered as ATV/RTV300/100 mg QD in healthy subjects• To assess the effects of ATV/RTV 300/100 mg QD on the steady-state PK of VOR 200 mg BID inhealthy…
Primary objective: To evaluate the influence of fosamprenavir/ritonavir on single-dose pharmacokinetics of olanzapine in healthy volunteersSecondary objective: To evaluate the safety of fosamprenavir/ritonavir combined with single-dose olanzapine in…
The primary objective is to determine the maximum tolerated dose (MTD) of docetaxel (as ModraDoc001) that can safely be administered to patients with cancer in a bi-daily weekly schedule.
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: 1/ To determine the higher of the tolerated dose of INC280 tablets with food between 300 and 400 mg BID in patients with cMET dysregulated advanced solid tumors. 2/ To assess the PK of INC280 with food.Secondary: To assess the safety of…
To quantitatively determine the absorption and excretion of docetaxel (as ModraDoc005 10 mg tablets) after administration of a single low dose and a single high dose of oral docetaxel in combination with ritonavir.
Primary objective:To compare the effect of multiple dose atazanavir/cobicistat on the multiple dose phar-macokinetics of daclatasvir with the effect of atazanavir/ritonavir on the multiple dose of daclatasvir by intra-subject comparison in healthy…
* To determine the DLT and the MTD/RP2D of docetaxel as ModraDoc006/ritonavir that can be administered safely to patients with NSCLC in a bi-daily weekly schedule, following platinum doublet first-line treatment.
Primary phase 1: To determine MTD and/or RP2D of INC280 incombination with erlotinibPrimary phase 2: To compare the antitumor activity of INC280 alone, and INC280 in combination with erlotinib, vs platinum with pemetrexed, as measured by Progression…
The aim of this prospective, multicentre randomized phase II study is to evaluate the safety and efficacy of the combination of capmatinib and spartalizumab in subjects with EGFR weight (for exon 19 deletions and exon 21 L858R substitution mutations…
Primary: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity of…