Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-27 @ 1:28 AM
Study NCT ID:
NCT01613768
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2012-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Phase II Trial of Eribulin for Locally Advanced Refractory or Metastatic Salivary Gland Cancers
Status:
COMPLETED
Status Verified Date:
2018-08
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:
Researchers are doing a research study to examine the use of eribulin (eribulin mesylate) in patients with salivary gland cancer. Researchers want to know if eribulin is safe and effective in treating salivary gland cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. Evaluate the response rate of eribulin per Response Evaluation Criteria In Solid Tumors (RECIST) in patients with locally advanced refractory or metastatic salivary gland cancer (SGC).
SECONDARY OBJECTIVES:
I. Determine the safety and toxicity of eribulin in patients with locally advanced refractory or metastatic SGC.
II. Evaluate the duration of response and time-to-progression.
OUTLINE:
Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
I. Evaluate the response rate of eribulin per Response Evaluation Criteria In Solid Tumors (RECIST) in patients with locally advanced refractory or metastatic salivary gland cancer (SGC).
SECONDARY OBJECTIVES:
I. Determine the safety and toxicity of eribulin in patients with locally advanced refractory or metastatic SGC.
II. Evaluate the duration of response and time-to-progression.
OUTLINE:
Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00892 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |