Trial Outcomes & Findings for Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer (NCT NCT03630120)

NCT ID: NCT03630120

Last Updated: 2021-07-14

Results Overview

Median time-to-discontinuation (TTD) of treatment per study arm, due to Progressive Disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

2 years

Results posted on

2021-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care: DTC Standard of Care (SOC) TKI Therapy for Differentiated Thyroid Cancer (DTC): Lenvatinib + Sorafenib.	Adaptive Care: DTC SOC followed by Adaptive Care TKI Therapy for DTC Participants with \>=50% drop: Lenvatinib + Sorafenib. 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. 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.	Standard of Care: MTC Standard of Care (SOC) TKI Therapy for Medullary Thyroid Cancer: Cabozantinib + Vandetanib.	Adaptive Care: MTC SOC followed by Adaptive Care TKI Therapy for MTC Participants with \>=50% drop: Cabozantinib + Vandetanib. 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. 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.
Overall Study STARTED	2	2	1	1
Overall Study COMPLETED	2	1	0	0
Overall Study NOT COMPLETED	0	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care: DTC Standard of Care (SOC) TKI Therapy for Differentiated Thyroid Cancer (DTC): Lenvatinib + Sorafenib.	Adaptive Care: DTC SOC followed by Adaptive Care TKI Therapy for DTC Participants with \>=50% drop: Lenvatinib + Sorafenib. 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. 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.	Standard of Care: MTC Standard of Care (SOC) TKI Therapy for Medullary Thyroid Cancer: Cabozantinib + Vandetanib.	Adaptive Care: MTC SOC followed by Adaptive Care TKI Therapy for MTC Participants with \>=50% drop: Cabozantinib + Vandetanib. 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. 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.
Overall Study Disease progression	0	1	1	1

Baseline Characteristics

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