Clinical trials: Lenvatinib
P-glycoprotein, Healthy Volunteers
A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy Volunteers
The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and P-glycoprotein induction on lenvatinib…
- Trial name
- NCT02199392
- Testing
- Lenvatinib
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Renal Impairment, Disease Severity
A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects
The purpose of this multicenter, open-label, non-randomized, single, oral dose, sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg) administered to healthy subjects and to subjects with…
- Trial name
- NCT02199379
- Testing
- Lenvatinib
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Hepatocellular Carcinoma
HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC
The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma.
- Trial name
- NCT06364007
- Testing
- HAIC+STRIDE+Len
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Sulai Liu
Hepatocellular Carcinoma
DEB-TACE Plus Lenvatinib or Sorafenib or PD-1 Inhibitor for Unresectable Hepatocellular Carcinoma
Transarterial chemoembolization (TACE) based on drug-eluting beads (DEB-TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the long-term survival is still low after DEB-TACE treatment.
- Trial name
- NCT04229355
- Testing
- DEB-TACE plus Sorafenib, DEB-TACE plus Lenvatinib, DEB-TACE plus PD-1 inhibitor
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Guangxi Medical University
Hepatic Impairment, Hepatic Function
A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)
This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh system, who will be matched with normal…
- Trial name
- NCT02421042
- Testing
- Lenvatinib
- Where
- 5 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy Volunteers
The study will be conducted in adult healthy participants and will consist of two phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a Screening Period and a Baseline Period.
- Trial name
- NCT02792829
- Testing
- Lenvatinib
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Renal Cell Carcinoma
Neoadjuvant Pembrolizumab and Lenvatinib for Renal Cell Carcinoma
This study will evaluate the effect of investigational drugs, pembrolizumab alone or pembrolizumab with lenvatinib, on the immune systems response to kidney cancer when given before and after surgery to remove kidney cancer.
- Trial name
- NCT05733715
- Testing
- Pembrolizumab infusion, Lenvatinib tablet
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Abramson Cancer Center at Penn Medicine
Healthy Volunteers
Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers
This will be a randomized, single dose, open-label, three-treatment period crossover study in healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the level of lenvatinib Type-C crystal are…
- Trial name
- NCT02723630
- Testing
- Lenvatinib 10 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Intrahepatic Cholangiocarcinoma
D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC
This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.
- Trial name
- NCT06643208
- Testing
- TACE-HAIC, Envafolimab and Lenvatinib
- Where
- China
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Fujian Provincial Hospital
Ovarian Cancer, Epithelial
Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer
This study is a single-arm, open-label, exploratory clinical study, the main purpose is to evaluate the combination of envafolimab, lenvatinib VP-16 in the treatment of platinum-resistant recurrent epithelial ovarian…
- Trial name
- NCT05422183
- Testing
- Envafolimab, Lenvatinib, VP-16
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Zhongda Hospital
Cancer
E7080 Food Effect Study in Healthy Subjects
This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization.
- Trial name
- NCT01240408
- Testing
- HOPE
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Hepatic Impairment; Renal Impairment
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants.
- Trial name
- NCT02998775
- Testing
- Plasma Sampling
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Refractory Solid Tumors, Lymphomas
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization.
- Trial name
- NCT01525394
- Testing
- Lenvatinib, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Pharmacokinetic Study to Assess the Influence of Simultaneous CYP3A4 and P-glycoprotein Inhibition on E7080 Pharmacokinetics Following Single Dose Oral Administration of 5 mg E7080 to Healthy Volunteers
The purpose of this study is to assess the influence of simultaneous CYP3A4 and p-glycoprotein inhibition on lenvatinib pharmacokinetics following a single oral dose of 5 mg lenvatinib.
- Trial name
- NCT02198170
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.