An Open-Label, Multicenter, Phase 1 Study of E7386 in Subjects With Selected Advanced Neoplasms

Eisai Clinical Trials

Protocol # E7386-G000-101

Study Overview

Study Compound: E7386

Drug Name: N/A

Registry #: NCT03264664, EudraCT: 2016-004881-25

Trial Period: Jul 2017 -

Indication: Advanced Neoplasms

Primary Endpoint: 1. Number of Participants With Dose-limiting Toxicities (DLTs)

2. Recommended Phase 2 Dose (RP2D)

3. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Population
Males and females (age 18 years and over)
Study Status
Ongoing, but not recruiting participants
Study Phase
Phase 1
Countries
United Kingdom, United States See moreSee less

Clinical Trial Documents

Clinical Study Report Synopsis

No download available

Plain Language Protocol Synopsis (PLPS)

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Plain Language Summary of Results (PLS)

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Publication reference citation

Evans TRJ, Cook N, El-Khoueiry A, Pinato DJ, Tran NH, Hsiehchen D, Mena E, Meyer T, Wu J, Pathak SM, Paoletti C, Dutta L, Okpara CE, Lopez JS. A first-in-human, open-label multicentre Phase 1 study of the orally administered E7386 in patients with selected advanced neoplasms. Br J Cancer. 2026 Jun 4. doi: 10.1038/s41416-026-03488-w. Online ahead of print.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is not available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR