NCT01613768

Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer

Phase II Trial of Eribulin for Locally Advanced Refractory or Metastatic Salivary Gland Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Salivary Gland Cancer
• Stage IVA Salivary Gland Cancer
• Stage IVB Salivary Gland Cancer
• Stage IVC Salivary Gland Cancer

Interventions

Type	Name	Description
DRUG	eribulin mesylate	Given IV

Timeline

• Start date: 2012-05-08
• Primary completion: 2017-08-23
• Completion: 2017-08-23
• First posted: 2012-06-07
• Last updated: 2018-09-28
• Results posted: 2018-08-10

Locations

1 site across 1 country: United States