5 results
primary objective: To evaluate the long-term safety and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis (CF), homozygous or heterozygous for the F508del-cystic fibrosis transmembrane conductance regulator (…
Primary ObjectiveTo evaluate the efficacy of lumacaftor in combination with ivacaftor throughat Week 24 in subjects with cystic fibrosis (CF) who are homozygous for the F508del CFTR mutation on the CF transmembrane conductance regulator (CFTR)…
The primary objective of this study is to:* To determine the PD profiles for treatment doses of dalteparin in pediatric subjects of different ages with or without cancer and VTE, using anti-Xa levels and a population PD analysis methodology;* To…
Evaluate the antitumor activity of nemvaleukin alfa (*nemvaleukin*, ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancerSecondary Objectives:Evaluate the antitumor activity of…
Phase 1b Primary Objective: 1. To establish the initial safety and determine a recommended Phase 2 dose (RP2D) of vofatamab in combination with pembrolizumabPhase 2 Primary Objectives: 1. To evaluate the safety and tolerability of vofatamab plus…