Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519896
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2007-08-21
Brief Title:
Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well giving sunitinib malate works in treating patients with iodine-refractory recurrent or metastatic thyroid cancer Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the response of sunitinib sunitinib malate per Response Evaluation Criteria in Solid Tumors RECIST criteria in patients with recurrentmetastatic iodine refractory well differentiated thyroid carcinoma WDTC or medullary thyroid carcinoma MTC
SECONDARY OBJECTIVES
I Evaluate early positron emission tomography PET changes in patients with WDTC and MTC treated with sunitinib
II Determine the safety and toxicity of sunitinib given as a continuous treatment in patients with WDTC and MTC
III Evaluate the effect of sunitinib therapy on overall survival duration of response and time-to-progression
IV Evaluate serial tumor markers thyroglobulin WDTC or calcitonin MTC during therapy These measurements will not be used to define disease progression or response
V Correlate changes in serial tumor markers with radiologic response
OUTLINE
Patients receive sunitinib malate orally PO once daily QD Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then for 2 years
I Evaluate the response of sunitinib sunitinib malate per Response Evaluation Criteria in Solid Tumors RECIST criteria in patients with recurrentmetastatic iodine refractory well differentiated thyroid carcinoma WDTC or medullary thyroid carcinoma MTC
SECONDARY OBJECTIVES
I Evaluate early positron emission tomography PET changes in patients with WDTC and MTC treated with sunitinib
II Determine the safety and toxicity of sunitinib given as a continuous treatment in patients with WDTC and MTC
III Evaluate the effect of sunitinib therapy on overall survival duration of response and time-to-progression
IV Evaluate serial tumor markers thyroglobulin WDTC or calcitonin MTC during therapy These measurements will not be used to define disease progression or response
V Correlate changes in serial tumor markers with radiologic response
OUTLINE
Patients receive sunitinib malate orally PO once daily QD Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-01305 | REGISTRY | CTRP Clinical Trial Reporting Program | None |