4 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…
Primary:* To prove the superiority of a 48-weeks treatment with 3.2 g/day delayedreleasephosphatidylcholine (LT-02) versus placebo for the maintenance ofremission in patients with ulcerative colitis (UC)Secondary:* To study safety and tolerability…
The objective of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of ALKS 6610 after single ascending oral doses in healthy adult subjects.
This study will evaluate the efficacy and safety of multiple therapies that are selected using somatic alterations and potential predictive biomarkers identified via NGS assays in patients with solid tumors: