10 results
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 evaluate the safety and tolerability of adding multiple oral doses of HTL0018318 in elderly volunteers taking donepezil at steady state.* To compare the pharmacokinetic profiles of HTL0018318 and donepezil when given alone and in combination at…
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…
Main objectives Part 1• To evaluate the safety and tolerability of a single oral dose of HTL0018318, administered at one of at least three ascending dose levels (maximum of 8 ascending dose levels), in healthy younger adult male subjects.• To…
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…
1. To evaluate the safety and tolerability of ascending multiple oral doses of HTL18318 in healthy adult male and female subjects.2. To evaluate the pharmacokinetics of ascending multiple oral doses of HTL18318 in healthy adult male and female…
To evaluate the effect of BIVV020 on the durabilityof platelet response in participants withpersistent/chronic immune thrombocytopenia (ITP)Secondary• To assess the safety and tolerability of BIVV020• To assess the pharmacokinetics (PK) of BIVV020•…
• 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.
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…
• 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…