Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer

Summary

Participants will have been diagnosed with advanced progressive thyroid cancer and are about to start treatment with a tyrosine kinase inhibitor (TKI).

The purpose of this study is to evaluate the efficacy and tolerability of tyrosine kinase inhibitor therapy (Lenvatinib or Sorafenib for differentiated thyroid cancer \[which includes papillary thyroid cancer, follicular thyroid cancer, and poorly differentiated thyroid cancer\]; and Cabozantinib or Vandetanib for medullary thyroid cancer) through adaptive (intermittent) versus conventional (continuous) regimen.

Conditions

• Thyroid Cancer
• Thyroid Cancer, Medullary
• Differentiated Thyroid Cancer
• Papillary Thyroid Cancer
• Follicular Thyroid Cancer
• Poorly Differentiated Thyroid Gland Carcinoma

Interventions

DRUG

Lenvatinib

Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment. Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

DRUG

Sorafenib

Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment. Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

DRUG

Cabozantinib

Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment. Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

DRUG

Vandetanib

Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment. Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Christine H. Chung, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-06

Primary Completion

2019-11-14

Completion

2019-12-05

FDA Drug

Yes

Countries

• United States

Study Locations