E7386 for Advanced Cancer

Recruiting at 9 trial locations

Overseen By Eisai Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eisai Inc.

Must be taking: Vitamin D

Must not be taking: CYP3A4 inducers/inhibitors

Disqualifiers: Active malignancy, Brain metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically those that are known potent CYP3A4 inducers/inhibitors or sensitive substrates, at least 4 weeks before starting the study drug. If you're on such medications, you may need to stop them before participating.

Eligibility Criteria

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.

Inclusion Criteria

Ability to comply with protocol

I am 18 years old or older.

I am fully active or can carry out light work.

Exclusion Criteria

I haven't had any cancer except for certain types in the last 2 years.

I have recently undergone treatment for cancer.

I am taking medication that affects CYP3A4 enzymes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive E7386 orally twice daily in 28-day cycles to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D)

28 days per cycle

Dose Expansion

Participants continue to receive E7386 at the determined RP2D to further assess safety and efficacy

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 6 years and 10 months

Treatment Details

Interventions

• E7386

Trial Overview 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.

Participant Groups

Group I: E7386 BID Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University