7 results
PRIMARY OBJECTIVES Part I - To evaluate the efficacy (as measured by PFS) of GDC-0941 340 mg +carboplatin * paclitaxel (Arm A) versus carboplatin * paclitaxel (Arm B) in all patients with squamous NSCLC -To evaluate the efficacy (as measured by PFS…
The primary objectives of this study are as follows:* To assess the safety and tolerability of escalating single and multiple doses of GS-5745 in subjects with moderate to severe ulcerativecolitis (UC) as assessed by adverse events (AEs), and…
A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication, may help to tailor optimal therapy. Therefore in this study…
Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…
To evaluate the effect of baricitinib 4-mg QD and background standard-of-care therapy compared with placebo and background standard-of-care therapy on SLE disease activity.
PrimaryTo evaluate the long-term safety and tolerability of baricitinib in patients with SLE.
The primary objective is to test the hypothesis that baricitinib high dose level in combination with topical corticosteroids (TCS) or baricitinib medium dose level in combination with TCS is superior to placebo in combination with TCS in the…