10 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…
To characterize the multiple-dose pharmacokinetics of varenicline in adolescent maleand female smoking subjects
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 objective of the study is to perform a set of hypothesis-driven analyses on the study data set, aiming to correlate established biomarkers (obtained clinically, from brain MRI, from CSF, from known genetic factors, and from monitoring of…
This study is aimed to determine the efficacy of varenicline in reducing EDS in PD patients.
The primary objective is to develop algorithms that define digital biomarkers for disease progression in Progressive Supranuclear Palsy patients. The biomarkers, when developed systematically, can eventually serve as primary or secondary clinical…
The first objective is to validate novel digital biomarkers for disease progression in de novo Parkinson*s disease patients. The biomarkers can eventually serve as a primary clinical endpoint in additional future clinical studies. As part of this…
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…