10 results
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
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 purpose of this Clinical investigation is to further evaluate the safety and performance of the EnligHTN* Renal Denervation System in the treatment of patients with uncontrolled hypertension.
The aim of this post-CE study is to collect data on the effects of renal sympathetic denervation on the insulin resistance and muscle sympathetic nerve activity (MSNA) in patients with metabolic syndrome and associated hypertension.
To determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity (MSNA) in patients with metabolic syndrome at 3 months after renal denervation.
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-…
Primary: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity of…
Phase I partPrimary:* Determine the maximum tolerated dose (MTD) or the recommended phase II dose (RP2D).Secondary:* Safety and tolerability, * ORR, duration of response (DOR), disease control rate (DCR), progression free survival (PFS) and time to…
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…