Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
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|ClinicalTrials.gov Identifier: NCT01613768|
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Salivary Gland Cancer Stage IVA Salivary Gland Cancer Stage IVB Salivary Gland Cancer Stage IVC Salivary Gland Cancer||Drug: eribulin mesylate||Phase 2|
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).
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.
I. Evaluate overall survival.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Eribulin for Locally Advanced Refractory or Metastatic Salivary Gland Cancers|
|Actual Study Start Date :||May 8, 2012|
|Primary Completion Date :||August 23, 2017|
|Study Completion Date :||August 23, 2017|
Experimental: Treatment (eribulin mesylate)
Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: eribulin mesylate
- Overall response rate, including both complete and partial responses, as defined by RECIST 1.1 criteria [ Time Frame: Up to 30 days after completion of study treatment ]Summarized using frequencies and percentages.
- Duration of response [ Time Frame: Date of the first objective assessment of partial response (PR) or complete response (CR) to the first date of disease relapse or death from any cause, assessed up to 30 days after completion of study treatment ]Will be reported as median values.
- Time to progression [ Time Frame: Date of enrollment to the first date of radiographic progression of disease per RECIST 1.1 criteria, assessed up to 30 days after completion of study treatment ]Will be reported as median values.
- Disease control rate (DCR), defined as stable disease + partial response rate [ Time Frame: Up to 30 days after completion of study treatment ]Summarized using frequencies and percentages.
- Toxicity rates described as the overall percentage of patients experiencing grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ]Summarized using frequencies and percentages.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613768
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Renato Martins||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|