8 results
The aim of this extension trial is to provide BIBF 1120 treatment for all patients who have completed the 52 weeks treatment period and the follow up period in the phase III placebo controlled parent trial 1199.34, who may have experienced benefit…
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…
to offer continuation of BIBF 1020 treatment for patients with IPF who have completed a prior clinical trial with that drug.establish the long term tolerability and safety profile of BIBF 1120 in IPF.
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…
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 objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.
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…