7 results
Primary objective: To study the influence of repeated oral administration of ketoconazole, a potent CYP3A4 inhibitor, in a therapeutic dose on the plasma pharmacokinetics (PK) of eribulin administered via intravenous (IV) infusion.Secondary…
The primary objective of this study is to determine the excretion balance and to elucidate the metabolic pathway of eribulin in vivo after a single dose of carbon-14 radio-labeled eribulin (14C-eribulin), inpatients with advanced solid tumors.
Primary objective• To assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin following intravenous (IV) administrationSecondary objectives• To assess the safety of eribulin when co-…
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
Dual Primary objective: - To demonstrate the superiority of Dato-DXd compared to ICC by assessment of PFS in participants with inoperable or metastatic HR-positive, HER2-negative breast cancer, who have been treated with 1 or 2 lines of chemotherapy…
The project*s overarching aim is to diminish respiratory disease burden in moderate-late preterm born infants in their first 18 months of life. We have formulated the following specific objectives: 1. Determine whether the introduction of our follow…
Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…