NCT03833700

A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)

An Open-label Phase 1 Study of E7386 in Subjects With Advanced Solid Tumor Including Colorectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted to assess the safety and tolerability of E7386 in participants with solid tumor including CRC.

Detailed description

The study will be conducted in 3 parts: dose escalation part, expansion part 1 and expansion part 2. The study will consist of Primary Assessment Phase and Continuation Phase. Primary Assessment Phase will include Pre-treatment Phase, Treatment Phase and Extension Phase (in expansion parts only). After Treatment Phase, participants will be followed in follow-up period of Extension Phase (in expansion parts only). All participants who are still on study drug at the time of data cutoff date for the planned primary analysis will enter the Continuation phase and continue to receive E7386.

Conditions

• Solid Neoplasms
• Colorectal Neoplasms
• Gastrointestinal Tumors

Interventions

Type	Name	Description
DRUG	E7386	E7386 doses.

Timeline

• Start date: 2019-03-05
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2019-02-07
• Last updated: 2026-02-27

Locations

8 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study