10 results
Primary* Compare progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria inSolid Tumors (RECIST) v1.1 between treatment armsKey Secondary* Compare overall survival (OS) between treatment arms* Compare PFS by…
The primary objective of this study is to evaluate the effect of obicetrapib on the risk of major adverse CV events (MACE), including CV death, non-fatal MI, non-fatal stroke, or non-elective coronary revascularization.
Demonstrate that with contemporary cardiac CT scan protocols good opacification of the coronary arteries can be achieved, that is similar to low-osmolar contrast media injected at the same iodine delivery rate. In addition, we will investigate the…
The primary objective of this study is to evaluate the pharmacodynamics (PD) (apolipoproteins/lipid particles and cholesterol efflux) of obicetrapib in cerebrospinal fluid (CSF) and plasma (apolipoproteins/lipid particles) in patients with early…
Primary ObjectiveTo evaluate the antitumor activity of tucatinib given in combination with trastuzumab in subjects with previously treated, locally-advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) overexpressing/…
Synopsis, page 4-5OBJECTIVES:The primary objective of this study is to evaluate the effect of obicetrapib on LDL-C levels at Day 84.The secondary objectives of this study include the following:• To evaluate the effect of obicetrapib on LDL-C levels…
The primary objective of this study is to evaluate the effect of obicetrapib on LDL-C levels at Day 84. The secondary objectives of this study include the following: - To evaluate the effect of obicetrapib on fasting apolipoprotein B (ApoB), non-…
To evaluate safety and feasibility of neoadjuvant chemotherapy-free regimen with trastuzumab, pertuzumab and tucatinib in stage II-III HER2-positive breast cancer.
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and mFOLFOX6 in comparison to mFOLFOX6 given with or without either bevacizumab or cetuximab as first-line (1L) treatment in adults with HER2 positive (HER2+)…
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and pertuzumab as maintenance therapy in subjects with advanced HER2+ breast cancer who have had prior treatment with a taxane, trastuzumab, and pertuzumab.