Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03630120
Status:
TERMINATED
Last Update Posted:
2021-07-14
First Post:
2018-08-10
Brief Title:
Adaptive Tyrosine Kinase Inhibitor TKI Therapy In Patients With Thyroid Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Adaptive Tyrosine Kinase Inhibitor Therapy In Patients With Advanced Progressive Thyroid Cancer
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Population Patients with advanced progressive 131I-refractory DTC or MTC will be enrolled to this study Forty-five patients responding to TKI therapy defined as 50 drop in tumor marker level within the first two months of treatment will be randomized to receive TKI therapy either through adaptive intermittent or conventional continuous regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None