14 results
2.1 Primary objectiveTo assess the rate of no progression (NPR) at 8 weeks following treatment with the combination of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible EGFR TKI*s (gefitinib or…
Primary• To evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-…
The primary objective of the study is to evaluate a dose-response signal of IFX-1 in subjects with HS according to the HiSCR at Week 16. The secondary objectives of the study are:* To assess the efficacy of IFX-1 using additional outcome measures*…
The main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria.
The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.
The purpose of this study is to investigate if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 2 different products, semaglutide and dulaglutide, in healthy volunteers. The 2 products…
The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.
Primary objectives: 1) Phase Ib: To estimate the MTD or RP2D of INC280 in combination with gefitinib in NSCLC patients who have c-MET dysregulation. 2) Phase II: To estimate overall clinical activity of INC280 in combination with gefitinib in NSCLC…
The primary objective of this study is to evaluate the disease control rate (DCR; confirmed complete response (CR) or partial response (PR), or stable disease (SD)) of gefitinib using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.…
To investigate the effect of various dietary interventions and co-administration of subcutaneous semaglutide on the pharmacokinetics of alectinib in NSCLC patients.
Primary Objectives:- Phase II: To explore the effect of IFX-1 on COVID-19 related severe pneumonia (hypothesis generating)- Phase III: To demonstrate the efficacy of IFX-1 to improve of symptoms and outcome of severe COVID-19 pneumonia (confirmative…
The primary objective is to demonstrate that semaglutide delays the progression of renal impairment and lowers the risk of renal and cardiovascular mortality compared to placebo, both added to standard-of-care, in subjects with type 2 diabetes and…
The primary objective is to evaluate the efficacy of IFX-1 treatment as a replacement for glucocorticoids [GC] therapy in subjects with GPA and MPA.Secondary objectives:*To assess safety and tolerability of IFX-1*To compare GC-induced toxicity of…
To study the effect of type 2 diabetes (T2D) on vascular wall inflammatory macrophage accumulation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed by drastically improving metabolic control, using potent…