5 results
The primary objective is to determine the optimal pharmacokinetic model of 68Ga-PSMA PET/CT, so 68Ga-PSMA PET/CT results can be quantified in prostate cancer.The secondary objectives are to determine whether the optimal kinetic model of 68Ga-PSMA…
Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
(1) To generate new clinical efficacy and safety data to support the registration of Insuman Implantable 400 IU/ml,(2) To ensure the continuation of the treatment of the patients already implanted and avoid pump explantation, up to the approval of…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…