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A Phase 2 Study of Lenvatinib in Combination with Radioactive Iodine Therapy in Patients with Progressive RAI-Sensitive Differentiated Thyroid Cancer

Status
Active
Cancer Type
Thyroid Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03506048
Protocol IDs
Winship4271-18 (primary)
NCI-2018-00144
IRB00101617
Study Sponsor
Emory University Hospital / Winship Cancer Institute

Summary

This phase II trial studies how well lenvatinib works when given together with standard of care iodine I-131 in treating patients with radioactive iodine-sensitive differentiated thyroid cancer. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Objectives

PRIMARY OJECTIVES:
I. Evaluate the efficacy of lenvatinib pretreatment along with radioactive iodine (RAI) in patients with previously treated RAI sensitive thyroid cancer.

SECONDARY OBJECTIVES:
I. Demonstrate the safety of the combination of lenvatinib and RAI in patients with Iodine sensitive differentiated thyroid carcinoma (DTC).
II. Assess dynamic changes in established serum based biomarkers of DTC (thyroglobulin [Tg] and Tg antibody).
III. Explore the utility of protein and genetic biomarkers to predict treatment efficacy.

OUTLINE:
Patients receive lenvatinib orally (PO) once daily (QD) for 8 weeks and up to 12 weeks in the absence of disease progression or unaccepted toxicity. Patients also receive iodine I-131 PO daily as standard of care.

After completion of study treatment, patients are followed up within 6 weeks, every 3 months for 1 year, and then periodically thereafter.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a state-supported nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education to improve cancer care for Georgians in rural, urban, and suburban communities across the state.