11 results
The primary objective of this study is to determine the equivalence accuracy of energy expenditure and resting heart rate measurement of newly developed software in reference to currently approved software. Secondary objective is to asses the…
The primary objective is to evaluate the ability of afatinib to control disease in pretreated patients with advanced non-small cell lung cancer harbouring HER2 exon 20 mutations.Secondary objectives are:* To evaluate secondary measures of clinical…
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 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,…
Primary Efficacy Objective (Blinded Treatment Period)• To demonstrate the efficacy of rilzabrutinib versus placebo in participants with refractory/relapsed ITP, based on the durability of platelet response during the last12 weeks of the 24-week…
Primary objectives- To evaluate the treatment efficacy by progression free survival (PFS) according to RECIST 1.1. - Quality of life assessmentSecondary objectives- To evaluate the treatment efficacy by growth modulation index- To evaluate the…
Primary objectives:Part A: To determine the recommended phase 2 dose and schedule (RP2D) of the selumetinib/afatinib combination in patients with KRASm and PIK3CAwt NSCLC and CRCPart B: To determine the progression free survival (PFS) of the…
Primary objective:To evaluate the area under the curve of afatinib compared to afatinib concomitantly used with esomeprazole and to afatinib used with esomeprazole 3 hours prior in patients with non-small cell lung cancer.Secondary objective:1.…
• to assess the efficacy of the sequential combination strategy of front-line afatinib-chemo, followed by a treatment with osimertinib-chemo in those patients that develop a T790M mutation as a mechanism of resistance.
The purpose of the study is to evaluate how effective rilzabrutinib is and how safe it is, in reducing the signs and symptoms in patients with chronic spontaneous urticaria (CSU), who continue to have symptoms despite the use of H1-antihistamines (…
• To determine the disease control rate at 18 weeks of afatinib and cetuximab treatment in patients with NSCLC harboring an EGFR exon 20 insertion mutation. • To assess anti-tumor activity of afatinib and cetuximab in NSCLC patients harboring an…