Active — Not RecruitingPhase 1

Study of E7386 in Participants With Selected Advanced Neoplasms

United States60 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 range18 Years

SexALL

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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)

Trial details

NCT IDNCT03264664

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-31

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