7 results
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 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…
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 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…
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…
To show a non-inferiority of continuous use of oral contraceptives for three months to long term pituitary down-regulation with a GnRH agonist for three months prior to present-day IVF/ICSI protocols in patients with severe endometriosis (ASRM…