Lenvatinib and Iodine Therapy in Treating Patients With Radioactive Iodine-Sensitive Differentiated Thyroid Cancer
Lenvatinib and Iodine Therapy in Treating Patients With Radioactive Iodine-Sensitive Differentiated Thyroid Cancer
Brief 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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of lenvatinib pretreatment along with radioactive iodine (RAI) in patients with previously treated RAI sensitive thyroid cancer.
SECONDARY OBJECTIVES:
I. To demonstrate the safety of the combination of lenvatinib and RAI in patients with Iodine sensitive differentiated thyroid carcinoma (DTC).
II. To assess dynamic changes in established serum based biomarkers of DTC (thyroglobulin [Tg] and Tg antibody).
III. To 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Lenvatinib in Combination With Radioactive Iodine Therapy in Patients With Progressive RAI-Sensitive Differentiated Thyroid Cancer
Actual Study Start Date: January 16, 2019
Estimated Primary Completion Date: February 3, 2022
Estimated Study Completion Date: February 3, 2022
Arm:
- Experimental: Treatment (lenvatinib)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 30 |
| Actual Study start date | 16 January 2019 |
| Estimated Study Completion Date | 03 February 2022 |