Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104871
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2005-03-03
Brief Title:
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-11
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 is studying how well bortezomib works in treating patients with metastatic thyroid cancer that did not respond to radioactive iodine therapy Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVE
I Determine the efficacy of bortezomib in terms of tumor response rate in patients with metastatic papillary or follicular thyroid cancer unresponsive to prior radioiodine therapy
SECONDARY OBJECTIVE
I Determine the clinical activity of this drug in terms of progression-free survival in patients treated with this drug
OUTLINE This is an open-label multicenter study Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed periodically
I Determine the efficacy of bortezomib in terms of tumor response rate in patients with metastatic papillary or follicular thyroid cancer unresponsive to prior radioiodine therapy
SECONDARY OBJECTIVE
I Determine the clinical activity of this drug in terms of progression-free survival in patients treated with this drug
OUTLINE This is an open-label multicenter study Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| CDR0000415376 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |
| 2004-0059 | OTHER | None | None |
| N01CM62202 | NIH | None | None |
| N01CM62203 | NIH | None | None |
| N01CM17003 | NIH | None | None |