6 results
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
Primary To test the hypothesis that at least 1 dose of LY2951742 (120 mg or 240 mg/month) is superior to placebo in the prevention of migraine headache in patients with chronic migraineKey Secondary Objectives If LY2951742 (120 or 240 mg/month) is…
The objective of this pivotal study is to assess the long-term safety, tolerability, pharmacokinetics and pharmacodynamics of RP103 in pediatric and adult patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support…
Comparison of steady-state cysteamine-trough WBC cystine levels between Cystagon® and RP103 over 3 months for each treatment period.
DOSE EXPLORATION:Primary:To determine the safety and tolerability of GSK2857916 in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each sub-study combination treatment.Secondary:…
Primary:To determine whether experimental regimens provide evidence for improved survival (randomization to death) over standard of care (SoC) therapy in NSCLC patients.Secondary:Milestone survival, measures of antitumor activity, safety and…