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NCT03264664 · ClinicalTrials.gov registry record · Phase 1

Study of E7386 in Participants With Selected Advanced Neoplasms

A Phase 1 study of Advanced Neoplasms, sponsored by Eisai.

Active
Registry status
Phase 1
Development phase
60
Enrollment target
10
Study locations

NCT03264664: Active Phase 1 study of Advanced Neoplasms, sponsored by Eisai.

NCT03264664 is a Phase 1 study of Advanced Neoplasms that is active but no longer recruiting, run by Eisai. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03264664, a Phase 1 study of Advanced Neoplasms, is active but no longer recruiting, sponsored by Eisai.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
10
Study locations

Study Summary

This study will be conducted to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.

Primary Outcome

DLTs are any of the pre-specified drug-related toxicities (any toxicities considered related to E7386) occurring during Cycle 1 as assessed by the investigator. DLTs will be assessed to determine the maximum tolerated dose.

Conditions Studied

Interventions

  • DRUG E7386

Study Locations (10)

California

  • USC Norris Comprehensive Cancer Center - Los Angeles
  • California Liver Research Institute - Pasadena

Other

  • Royal Free London NHS Foundation Trust, Royal Free Hospital - London
  • Imperial College Healthcare NHS Trust - London

Arizona

  • Mayo Clinic Comprehensive Caner - Phoenix

Florida

  • Mayo Clinic Comprehensive Cancer - Jacksonville

Minnesota

  • Mayo Clinic Comprehensive Caner - Rochester

Lanarkshire

  • The Beatson West of Scotland Cancer Centre - Glasgow

Lancashire

  • The Christie NHS Foundation Trust - Manchester

Surrey

  • Royal Marsden Hospital NHS Foundation Trust - Sutton

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2017-07-27
Est. Completion 2027-03-31
Phase Phase 1
Eisai

287 total trials

What the registry record for NCT03264664 still lists

NCT03264664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 1 condition, with Advanced Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which E7386 is the first listed.

NCT03264664 lists 10 locations in 8 states (California, Other, Arizona).

Frequently Asked Questions

What is clinical trial NCT03264664 about?

NCT03264664 is a clinical study titled "Study of E7386 in Participants With Selected Advanced Neoplasms". This study will be conducted to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.

What is the current status of trial NCT03264664?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-07-27. Estimated completion is 2027-03-31.

What conditions does trial NCT03264664 study?

This clinical trial studies the following conditions: Advanced Neoplasms.

What interventions are being tested in trial NCT03264664?

The interventions under investigation include: E7386 (DRUG).

Who is sponsoring clinical trial NCT03264664?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03264664 being conducted?

This trial has 10 study locations across Arizona, California, Florida, Minnesota, Lanarkshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03264664's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03264664, the US trial registry maintained by the National Library of Medicine. NCT03264664 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.