5 results
The purpose of the study is to investigate how quickly Danoprevir is absorbed and the extent of absorption and elimination from the body (this is called pharmacokinetics and bioavailability) when it is administered intravenously (IV) or orally alone…
Primary:To assess the safety and tolerability of Firdapse after single and multiple doses Secondary:Part 1 only: To determine the dose-related PK profile of single, escalating doses of Firdapse;Part 2 only: To assess the steady-state plasma PK and…
Primary:• To evaluate the ability of relugolix to achieve and maintain serum testosterone suppression to castrate levels (<= 50 ng/dL [1.7 nmol/L]) in men with androgen-sensitive advanced prostate cancer.Secondary:• To evaluate the time…
The aim of the current study is to extend the time to develop new disease progression in prostate cancer patients with recurrent disease in the form of limited metastases (<5) and in some cases possibly even cure by adding 6 months of ADT to…
All efficacy and safety objectives will compare enzalutamide plus leuprolide and enzalutamide monotherapyversus placebo plus leuprolide.