12 results
This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…
To demonstrate the superiority of S 95005 + bevacizumab over capecitabine + bevacizumab in terms of Progression-free survival (PFS) based on Investigator assessment in first-line treatment of patients with unresectable metastatic colorectal cancer…
The primary objective is to the safety of long term administration of etrasimod in subjects with moderately to severely active UC. The secondary objective is to assess the the long-term efficacy of etrasimod in subjects with moderately to severely…
Primary objective:To assess the bioequivalence of single-dose velpatasvir administered as a fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) when given with cola + omeprazole 40mg (test 1/trt A) compared to velpatasvir…
This protocol is designed to determine the safety, tolerability, and efficacy of SGI-110 in combination with irinotecan in previously treated patients with metastatic colorectal cancer who progressed on irinotecan.
Primary objective:To assess the bioequivalence of SOF/VEL as a crushed (test) tablet compared to a whole (reference) tablet in patients treated with SOF/VELSecondary objective:To evaluate the safety and tolerability of crushed SOF/VEL tablets in…
The purpose of the study is to investigate the effect of etrasimod on the values of specific ECG parameters. Importantly, the study will assess whether there is a prolongation of the QT interval following etrasimod treatment. When the QT interval is…
Main objective:*To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active Crohn's disease (CD).*To select an oral etrasimod dose, based on efficacy and…
Primary:* To evaluate the effects of etrasimod on esophageal eosinophilia in adult subjects with active eosinophilic esophagitis (EoE)* To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo in adult subjects with active…
To determine the influence of concomitant administration of Lonsurf with metformin and cimetidine on Lonsurf and metformin exposure.
The primary objective is to assess the efficacy of etrasimod when administered for 12 weeks on clinical remission in subjects with moderately to severely active ulcerative colitis (UC). The secondary objective is to assess the efficacy of etrasimod…
The primary objective is to assess the efficacy of etrasimod on clinical remission in subjects with moderately to severely active ulcerative colitis (UC) after 12 and 52 weeks of treatment. The secondary objective is to assess the efficacy of…