15 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…
The objective of this study is to assess the effects of an increased NE level on the trade-off between exploitation and exploration. More specifically, this study will compare the exploitative/explorative behavior of participants who received either…
Primary Objectives:- To investigate the effects of a single dose (plasma concentration) 5-HTP challenge test (5-HTP200mg/CBD100+50mg/granisetron2mg) on hypothalamic fMRS activation patterns in healthy male volunteers.Secondary Objectives:- To assess…
Primary:1. To establish the effect of MCP on the release of plasma AVP and subsequent ACTH and cortisol secretion in the absence of a 5HTP-challenge.2. To establish the effect of MCP on the release of plasma AVP and subsequent ACTH and cortisol…
We propose to conduct a study in healthy young and elderly subjects and patients diagnosed with mild to moderate AD, FTLD, or DLB where cholinergic and serotonergic challenges are given in a placebo-controlled, crossover fashion. Before each…
We propose to conduct a study in healthy subjects where a serotonergic challenge is given in a placebo-controlled, crossover fashion. Before each challenge, participants will be measured 1 time to define their baseline resting state networks (RSNs)…
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…
The purpose of this study is to find out if the combination of gemcitabine plus carboplatin and iniparib works better than gemcitabine and carboplatin alone in subjects with stage IV squamous non-small-cell lung cancer (NSCLC) that have not…
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)