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Microtubule Inhibitor

E7386 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Must not have

Use of drugs affecting CYP3A4 enzymes

Known HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6 years and 10 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug to treat advanced/recurrent cancer to find the safest/tolerable dose.

Who is the study for?

Adults with a life expectancy of at least 12 weeks and certain advanced tumors who've recovered from previous cancer treatments can join. They must have an ECOG Performance Status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Specific tumor types for different trial parts are required, along with measurable disease, normal organ function, and agreement to vitamin D supplements.

What is being tested?

The trial is testing the safety and tolerability of E7386, an oral medication for various advanced cancers. It aims to find the highest dose patients can take without serious side effects (MTD) and suggest a Phase 2 dose (RP2D). Participants will be selected based on their type of cancer and health status.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions to determine the drug's safety profile. Common side effects in trials like this may include nausea, fatigue, diarrhea, risk of infection due to lowered immune response, liver issues, skin reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My advanced cancer cannot be surgically removed and needs treatment, but there are no standard options left.

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My tumor can be easily reached for a biopsy.

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My cancer can be measured by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication that affects CYP3A4 enzymes.

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I have been diagnosed with HIV.

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I do not have any infections that need treatment.

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I am not taking any immunosuppressive medications.

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I have not used any experimental drugs or live vaccines recently.

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I have a heart condition that affects my heart's electrical activity.

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I cannot take pills or have a stomach condition affecting medication absorption.

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My brain cancer has not caused symptoms and is not getting worse.

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I have specific bone health issues or recent fractures.

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I have recently undergone radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6 years and 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 6 years and 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years and 10 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Dose-limiting Toxicities (DLTs)

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Accumulation Ratio (R) of E7386

Apparent Total Body Clearance (CL/F) of E7386

Area Under the Concentration Versus Time Curve (AUC) of E7386

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: E7386 BIDExperimental Treatment1 Intervention

E7386 will be administered as a single agent orally, initially twice daily (BID) continuously in 28 days treatment cycle. The dose will be escalated in cohorts of participants subject to safety data and the absence of DLTs. Based on the emerging data after completion of Dose Escalation Part, identifying MTD or RP2D, or after a decision is made to evaluate more than one potential RP2D level, a Dose Expansion Part will be initiated. Participants will continue to receive study treatment in extension phase until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study program.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

E7386

2019

Completed Phase 2

~110

0 / 15Eligibility criteria met