9 results
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.
OBJECTIVES AND HYPOTHESIS Primary ObjectiveThe primary objective is to evaluate the accuracy of the length-109 probe set panel in predicting mucosal healing (ie, improvement in the endoscopic appearance of the mucosa) at Week 6, as measured by the…
The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by more or equal to 5 joints with active arthritis despite MTX therapy…
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…
Primary Objective: To determine whether topical application of rapamycin can lead to reduction in size and/or number of fibrofolliculomas in BHD patients and may prevent the growth of new ones. Secondary Objectives: Safety, formula acceptability and…
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…
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…
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…
Primary Objectives* To evaluate the efficacy of golimumab in inducing clinical remission as assessed by the Mayo score,in pediatric participants with moderately to severely active ulcerative colitis (UC).* To evaluate the safety profile of golimumab…