13 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…
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 assess the safety and the efficacy on the activity part of the Steatosis Activity Fibrosis (SAF) histological score (inflammation and ballooning) of a 24-week treatment with two doses of lanifibranor (800, 1200 mg/24h) in NASH adult patients.
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…
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: 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…
The objective of this study is to test the CBM eHealth app, with regard to the influence of the app on implicit fatigue self-concept and on explicitly experienced fatigue and vitality, both immediately after finishing the two-weekly training.…
The objective of this study is to investigate whether BTA injection in the pelvic floor muscle is an effective treatment for patients with chronic pelvic pain and pelvic floor hypertonicity.
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…
1. Primary Objective The primary objective of this study is to assess the effect of lanifibranor alone compared toplacebo and the effect of lanifibranor in combination with empagliflozin compared to placeboon HbA1c after a 24-week treatment duration…
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…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)