35 results
The purpose of this study is: • To examine how the combined oral contraceptive pill, which consists of 30 micrograms ethinyl-estradiol and 150 micrograms levonorgestrel (for instance Microgynon 30®), will be absorbed, metabolized and excreted by the…
Primary objectives:To determine the objective tumor response (CR + PR) after 3 weeks of erlotinibSecondary objectives: To describe predictive markers for response:- radiological response (FDG-PET/CT)- EGFR mutations (HER1)To determine (diseasefree)…
Primary:•Efficacy of combination of erlotinib and sorafenib as determined by the rate of no progression at 6 weeks.•Determination of the impact of concomitant administration of sorafenib on the pharmacokinetics (PK) of erlotinibSecondary:•Efficacy…
Primary objective: Efficacy of erlotinib plus bevacizumab subsequent to the combination of carboplatin, paclitaxel and bevacizumab as determined by the maximum achieved disease control rate (DCR, complete response, partial response, or stable…
Primary: 1. Effect of the highly potent CYP3A4 inhibitor ritonavir on the pharmacokinetics (PK) of erlotinib, measured as AUC0-24h, AUCmean, Cmax and CminSecondary objective 1. Safety of the CYP3A4 moderator ritonavir in combination with erlotinib,…
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…
In this study we want to determine the erlotinib concentrations in blood after administration of erlotinib with water or whole milk with and without an antacid .
Unless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + nab-paclitaxel (Arm B) versus carboplatin + nab- paclitaxel (Arm C)• Atezolizumab + carboplatin + paclitaxel…
The main objective of this pilot study is to determine PKI concentration in tumor tissue after approximately two weeks of treatment.
The objective of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…
To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to…
Primary: To compare progression-free survival (PFS) between erlotinib alone and cisplatin-pemetrexed-erlotinib in patients with EGFR mutated NSCLC locally advanced and metastatic disease stage IIIB and IV.Secondary: To characterize toxicities of…
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
Primary Objectives:-To evaluate if the treatment of Low Risk HB can be reduced (Group B1)-To compare different induction treatment regimens for Intermediate risk HB (Group C)-To compare different post induction treatment regimens for High Risk HB (…