6 results
The objectives of the study are as follows:Primary:• Part 1: To assess the pharmacokinetics and relative bioavailability of three different formulations of PA101 (4% cromolyn sodium with and without mannitol, and 6% cromolyn sodium without mannitol…
Primary:* To determine the efficacy profile of PA101 delivered via a high efficiency nebulizer (eFlow®,PARI) in comparison with placebo following 6 weeks of treatment in patients with indolentsystemic mastocytosis (ISM) who are symptomatic despite…
To assess the treatment effect of BEZ235 relative to everolimus on progression free survival in patients with advanced pancreatic neuroendocrine tumors who have not been previously treated with an mTOR inhibitor.
To determine whether treatment with BEZ235 plus best supportive care prolongs PFS compared with placebo plus best supportive care in patients with advanced pancreas NET, after failure of a mTOR inhibitor therapy
Efficacy of BEZ235 on objective response rate according to RECIST 1.1
- To evaluate the treatment efficiency by time to progression according to RECIST 1.1