Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-02-24 @ 8:48 AM
Study NCT ID:
NCT03833700
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2019-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)
Sponsor:
Eisai Co., Ltd.
Organization:
Study Overview
Official Title:
An Open-label Phase 1 Study of E7386 in Subjects With Advanced Solid Tumor Including Colorectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: