3 results
Primary objective: Determine whether treatment with a PI3K inhibitor (BYL719 or buparlisib) plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with hormone receptor-positive HER2-…
Part A: healthy volunteers (n=up to 15)Primary/safety objective: - To assess the safety, tolerability and pharmacokinetics of a single IV dosage of OTL78 Secondary objective: - To assess the pharmacodynamics of OTL78 by measuring the temporal…
Primary Objectives:• To assess the safety and tolerability of DCC 3014.• To characterize the pharmacokinetic (PK) profile of DCC 3014.• To determine the maximum tolerated dose (MTD) of DCC 3014.• To determine the recommended Phase 2 dose (RP2D) of…