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Study of an Investigational Drug, E7386 Plus Lenvatinib in People with Endometrial Cancer after Chemotherapy and Immunotherapy

https://www.facingourrisk.org/research-clinical-trials/study/355/study-of-a-new-drug-e7386-in-combination-with-lenvatinib-in-people-with-previously-treated-endometrial-cancer

Clinicaltrials.gov identifier:
NCT04008797 (https://clinicaltrials.gov/show/NCT04008797)

Treatment
Treatment study for people with previously treated endometrial cancer

Study Contact Information:

For inquiries, please contact Eisai Inquiry Service:

Eisai-chiken_hotline@hhc.eisai.co.jp


This study is an open-label, Phase 1b/2, randomized study of the oral medication E7386 plus the oral medication lenvatinib in people with endometrial cancer who had disease progression with platinum-based chemotherapy and anti-PD-(L)1 immunotherapy.

The study’s goal is to determine the safety and effectiveness of the drug E7386 in combination with lenvatinib in participants with advanced or recurrent endometrial cancer that has progressed after platinum-based chemotherapy and anti-PD-(L)1 immunotherapy.

The key objectives are to:

Approximately 120 study participants will be randomized to one of the following treatments:

The Dose Optimization part of the study involves the following:

Study procedures will include laboratory blood tests, urine analysis, vital signs, physical examinations, cardiac monitoring, scans to evaluate the extent of disease, bone scans to determine bone density.

Reimbursement may be available to study participants, which may include travel, lodging, and meals.


This Study is Open To:

Some requirements for participation include the following:

This Study is Not Open To:

Some exclusions for this trial include the following:


About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.