10 results
Primary Objective:- To demonstrate the superiority of palbociclib in combination with fulvestrant (with or without goserelin) over fulvestrant alone (with or without goserelin) in prolonging investigator-assessed PFS in women with HR+/HER2-negative…
The primary objective of this study is to determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) compared to letrozole in combination with palbociclib in patients with ER +, HER2-advanced breast cancer…
Primary ObjectivesTo determine the pharmacodynamic effect of linsitinib in the tumourTo evaluate the safety and tolerability of linsitinibSecondary ObjectivesTo determine the clinical outcomeTo conduct pharmacokinetic assays with linsitinib…
The objectives are:1. the effect of steady state concentrations of voriconazole and fluconazole on the steady-state pharmacokinetics of TMC125,2. the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of…
The objective of this study is to compare the bioavailability of 100 and 200 mg pills that are produced in different ways: coated or non-coated. Bioavailability means the amount of medication which is available for use in the body. In this study the…
Primary Objective:To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed…
The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…
To evaluate in a feasibility study whether low uptake on FES-PET at baseline is related to non-response to letrozole plus palbociclib treatment.
Primary: To compare the efficacy of palbociclib in combination with TMZ and IRN vs TMZ and IRN chemotherapy alone in the treatment of children, adolescents, and young adults with recurrent or refractory EWS.Secundary: To further compare the efficacy…
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…