NCT04008797

A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

An Open-label Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 301 (estimated)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s), and to determine the optimal dose of E7386 in combination with lenvatinib in endometrial carcinoma (EC) (for EC Dose Optimization Part only).

Detailed description

The Dose Escalation and Dose Expansion parts of the study have completed enrollment. The Dose Optimization part of the study is enrolling participants with endometrial carcinoma (EC) only.

Conditions

• Endometrial Neoplasms
• Neoplasms
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	E7386	E7386 dosing.
DRUG	Lenvatinib	Lenvatinib dosing.
DRUG	Doxorubicin	Doxorubicin dosing.
DRUG	Paclitaxel	Paclitaxel dosing.

Timeline

• Start date: 2019-07-11
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2019-07-05
• Last updated: 2026-03-24

Locations

106 sites across 10 countries: United States, Canada, China, Denmark, France, Italy, Japan, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study