8 results
The primary objective of the study is to determine the effect of atazanavir-induced hyperbilirubinemia on systemic activation of the innate immune response induced by human endotoxemia.Secondary objectives are:- To determine if the vascular…
Our primary objective is to investigate whether noradrenaline exerts immunomodulatory effects in humans in vivo during experimental human endotoxemia. This will be determined by comparing plasma levels of various pro- and anti-inflammatory cytokines…
PrimaryTo assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory teratoma with recent progressionSecondaryTo assess other measures of efficacy of LEE011 compared with placebo To assess safety and tolerability of…
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…
Primary: To estimate the MTD and/or RDE for each of the following three treatment arms in patients with myelofibrosis.* PIM447 plus ruxolitinib (doublet)* Ribociclib (LEE011) plus ruxolitinib (doublet)* PIM447 plus ruxolitinib and Ribociclib (LEE011…
Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…
PRIMARY- Phase Ib: To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 regimen (RP2R) of ribociclib and trametinib in patients with solid tumors- Phase II: To assess overall response rate (ORR) with the combination of…
The current trial aims to asses the safety of this combination in a phase I trial with olaparib dose escalation during two cycles of 177Lu-DOTATATE in salvage setting in patients with advanced GEP NET, progressive after initial PRRT.