40 results
To evaluate the efficacy of the drug combination. Translational work is aimed to explore pharmacodynamic, predictive and surrogate endpoint biomarkers in tumor tissue and blood.
To determine long-term outcome of patients with advanced non-squamous NSCLC harbouring at diagnosis EGFR mutations with and without T790M mutation and treated with the combination of erlotinib and bevacizumab.
Primary objective:To compare the effects of quick starting a combined oral contraceptive on follicular growth and hormonal parameters after ellaOne® or placebo intake.Secondary objective:To compare the effects of quick starting a combined oral…
see whether this treatment schedule is effective in EGFR-mutated NSCLC patients who have developed progression after treatment with EGFR-TKI monotherapy in standard dose before
This randomized, open label phase III trial will be performed in patients with squamous carcinoma of the lung. The objectives of the trial are to compare the efficacy of afatinib with erlotinib as maintenance and second-line treatment for this group…
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 objectivesTo confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs. placebo significantly increases trough FEV1 (defined as mean evaluation at 23 h 15 min and 23 h 45 min post dose) following 12 weeks of treatment in patients with…
To select targeted treatment based on ex vivo kinase activity inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for whom no standard treatment is available.
Primary objective: To demonstrate that QVA149 (110/50 *g o.d.) is superior to NVA237 (50 *g o.d.) with regard to the rate of moderate to severe COPD exacerbations during 64 weeks of treatmentSecondary objectives: To demonstrate that QVA149 (110/50 *…
The purpose of this clinical trial is to test whether treatment of patients with NSCLC with erlotinib plus sunitinib is better than treatment with erlotinib plus placebo. All patients enrolling in this study will receive treatment with erlotinib.
The main objective of this pilot study is to determine intratumoral concentrations of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.
To compare the effects on the APC- (Activated Protein C) resistance ratio (ETP-[endogenous throbin potential] based) between the pivotal phase III NOMAC-E2 batch and a commercial NOMAC-E2 batchTo compare the effects on all other metabolic parameters…
Primary objectiveTo evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the…
The primary objective of this study is to compare the Overall Survival (OS) of first-linemaintenance therapy with erlotinib versus erlotinib administered at the time of diseaseprogression in patients with histologically documented, advanced or…
To measure APC resistance and SHBG levels as indicators of the risk of venous thrombosis during use of the new developed combined oral contraceptive containing dienogest/estradiolvalerate (Qlaira®) compared with a combined oral contraceptive…
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 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 objective: To demonstrate the superiority of QVA 110/50 µg compared to both QAB149 150 µg and NVA237 50 µg in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 26 weeks of treatment in patients with moderate to…
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,…