E7820 for Leukemia

Recruiting at 8 trial locations

Overseen By Eytan Stein, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing E7820, a new type of oral medication for treating blood cancers in patients whose cancers have come back or did not respond to previous treatments and have certain genetic changes. The drug works by targeting faulty genetic processes in cancer cells to stop their growth.

Research Team

Eytan Stein, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with relapsed or refractory myeloid cancers, specifically AML, MDS, or CMML that have certain splicing factor gene mutations. They must have tried specific treatments without success and should not be pregnant or breastfeeding. Participants need to be in a stable enough condition to follow the study schedule.

Inclusion Criteria

My CMML did not improve after specific treatments.

My CMML cancer has returned after initially responding to treatment.

I am 18 years old or older.

Exclusion Criteria

My heart's electrical activity is irregular or I have a family history of similar issues.

I haven't had serious heart issues like heart failure, heart attack, or stroke in the last 6 months.

I am currently pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily administration of E7820, starting at 100 mg daily, with dose adjustments for toxicity

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• E7820

Trial Overview The trial is testing E7820's effectiveness for those with myeloid cancers who've had previous treatment failures. It focuses on patients whose cancer has returned after remission or hasn't responded to standard therapies.

Participant Groups

Group I: E7820 Experimental Treatment 1 Intervention

Each patient will receive daily administration of E7820. The starting dose for every patient will be 100 mg daily but the dose can subsequently be reduced if excessive toxicity is encountered.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Eisai Inc.

Industry 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