Active — Not RecruitingPhase 1

Study of E7386 in Participants With Selected Advanced Neoplasms

United States, United Kingdom60 participantsStarted 2017-07-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. have a Child Pugh status of B and C.
. clear invasion to the bile duct or portal vein invasion of Vp4.
. symptomatic gastric or esophageal varices per Investigator's clinical judgement.
. history of hepatic encephalopathy within 6 months prior to starting study drug.
. (Dose Expansion only) cannot be evaluated by either triphasic liver CT or triphasic liver MRI because of allergy or other contraindication to both CT and MRI contrast agents.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Dose-limiting Toxicities (DLTs)

Timeframe: Cycle 1 (28 days)

Recommended Phase 2 Dose (RP2D)

Timeframe: Cycle 1 (28 days)

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Timeframe: From the date of first dose of study drug up to 28 days after administration of study drug (up to approximately 6 years and 10 months)

Trial details

NCT IDNCT03264664

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Advanced Neoplasms trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. have a Child Pugh status of B and C.
. clear invasion to the bile duct or portal vein invasion of Vp4.
. symptomatic gastric or esophageal varices per Investigator's clinical judgement.
. history of hepatic encephalopathy within 6 months prior to starting study drug.
. (Dose Expansion only) cannot be evaluated by either triphasic liver CT or triphasic liver MRI because of allergy or other contraindication to both CT and MRI contrast agents.

What they're measuring

Number of Participants With Dose-limiting Toxicities (DLTs)

Timeframe: Cycle 1 (28 days)

Recommended Phase 2 Dose (RP2D)

Timeframe: Cycle 1 (28 days)

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Timeframe: From the date of first dose of study drug up to 28 days after administration of study drug (up to approximately 6 years and 10 months)