9 results
The primary objective of this Phase 1b study is to identify the maximum tolerated dose (MTD) and recommended phase II dose of the combination of temsirolimus and Caelyx® in patients with advanced or therapy refractory breast cancer, endometrial…
The primary hypothesis of this study is that ibrutinib compared with temsirolimus significantly prolongs PFS in subjects with relapsed or refractory MCL who have received at least 1 prior rituximab-containing chemotherapy regimen.
Primary:- Estimate independently assessed PFS in subjects with relapsed or refractory MCL.Secondary:- Estimate OS.- Estimate objective response rate (ORR), independently and investigator assessed.- Estimate investigator assessed PFS.- Assess safety…
Treatment of endometrial hyperplasia by an IUD that contains progesteron is more effective and has less side-effects than the treatment with progesteron oral.
Primary:To investigate the safety and tolerability of single oral administration of study medication in healthy postmenopausal females (Part I)To investigate the general safety and tolerability of the study medication in healthy postmenopausal…
To assess in a cohort of patients with established FAP:1 The efficacy of MPA in terms of reduction of number of colonic polyps, by means of Endoscopic Appearance of Polyposis (EAP) index.2 The effect on histological parameters and biological…
Primary objectiveAssessment of the duration of PFS after treatment with temsirolimus in heavily pre-treated metastatic RCC patientsSecondary objectivesEvaluation of the FLT-PET and FDG-PET:Measurement of 18F-FLT-PET-signal and FDG-PET-signal, and…
The primary hypothesis of this study is that the 6-month OS rate of patients with newly diagnosed stage 3B AL amyloidosis will exceed 50% after primary therapy with daratumumab
Primary• To determine the RP2D of crizotinib in combination with temsirolimus • To determine the safety and preliminary activity of single-agent crizotinib in ALK, MET or ROS1 positive tumors Secondary• To study the preliminary activity of…