NCT00859937

Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors

Phase II Trial of Dasatinib (BMS 354825) for Recurrent or Metastatic c-KIT Expressing Adenoid Cystic Carcinoma and Non-adenoid Cystic Malignant Salivary Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well dasatinib works in treating patients with malignant salivary gland tumors that have come back after treatment or have spread to other parts of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. Determine the objective response rate (complete response plus partial response) of dasatinib in adenoid cystic carcinoma (ACC). II. Determine the progression-free survival of dasatinib in ACC. SECONDARY OBJECTIVES: I. Determine the duration of response. II. Determine the stable disease rate and duration of stable disease. III. Determine progression-free survival. IV. Determine the median survival. V. Determine the overall survival. VI. Determine the safety and tolerability. TERTIARY OBJECTIVES: I. To examine biomarkers that relate to SRC proto-oncogene, non-receptor tyrosine kinase (Src) signal transduction and to correlate these biomarkers with clinical response to dasatinib in ACC and non-ACC malignant salivary gland tumors (MSGT). II. Determine if activating mutations in platelet-derived growth factor alpha polypeptide (PDGFA) and KIT are associated with response in ACC. OUTLINE: Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 8 weeks.

Conditions

• Malignant Salivary Gland Neoplasm
• Recurrent Salivary Gland Carcinoma
• Salivary Gland Adenoid Cystic Carcinoma
• Stage IV Major Salivary Gland Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Dasatinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2009-03-16
• Primary completion: 2013-01-30
• First posted: 2009-03-11
• Last updated: 2018-04-20
• Results posted: 2015-04-03

Locations

34 sites across 2 countries: United States, Canada