E7386 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Eisai Inc.

No Placebo Group

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.

Research Team

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.

Treatment Details

Interventions

• E7386 (Microtubule Inhibitor)

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