12 results
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…
To assess long term safety and toleralibility of Pitavastatin 4 mg QD. To assess the efficacy of Pitavastatin (4 mg) and simvastatin (40 mg and 80 mg QD) in terms of LDL-C target attainment (EAS and NCEP) following 16 weeks and 44 weeks of treatment…
The specific goals of the study are:- To identify which dose(s) of mecamylamine cause cognitive and memory impairment as demonstrated using the NeuroCart CNS test battery- To investigate the safety and tolerability of mecamylamine by comparison with…
Primary Objectives:• Assess the pharmacokinetic (PK) and pharmacodynamic (PD)/efficacy effects of 3 different single doses of EVP-6124 vs. placebo;• Assess the PK and PD/efficacy effects of the different combinations of 2 doses of donepezil and 3…
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- 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…
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…
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 objective:• Determine if ribociclib plus letrozole gives a >=100% improvement in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) as compared to chemotherapy in the surgical specimen*.Secondary objective• Study the…
Primary: To compare PFS between ribociclib plus fulvestrant to fulvestrant monotherapy (plus placebo) among men and postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for…
Primary objective of this study: evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR) by local investigator's assessment per RECIST v1.1secondary objectives: - Safety & tolerability of…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)