IRB #

STUDY00015341

Title

A Multicenter, Randomized, Double-Blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With 131I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 mg Daily Will Provide Comparable Efficacy to a 24-mg Starting Dose, But Have a Better Safety Profile

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of this study is to find out if a lower dose of lenvatinib will cause fewer side effects and work as well as the current dose for treating thyroid cancer.

Medical Condition(s)

Thyroid cancer

Eligibility Criteria

1. Confirmed diagnosis of differentiated thyroid cancer (DTC).
2. Evidence of disease progression within 12 months.
3. Must be refractory or resistant to RAI.
4. Must have adequately controlled blood pressure (less than or equal to 150/90).
5. Must have sufficient performance status and bone marrow function.

Other criteria apply.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Treatment may range from 6 months to 42 months. If you are still receiving study treatment at the time the study ends, you may continue taking commercially available lenvatinib or through an access program administered by the sponsor. Also, until the study ends, you or your family will be contacted by telephone or e-mail about every 3 months after your last dose of study drug to find out how you are doing overall, whether your cancer has worsened, and what anticancer medications you may be taking.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Eisai, Inc.

Recruitment End

12/31/2030

Compensation Provided

No


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