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Brief Title: Cabozantinib in Advanced Salivary Gland Cancer Patients
Official Title: The Efficacy of Cabozantinib in Advanced SAlivary Gland Cancer Patients, a Phase II Clinical Trial
Study ID: NCT03729297
Brief Summary: Phase 2 clinical trial on the efficacy of cabozantinib in locally advanced, recurrent and/or metastatic salivary gland cancer patients.
Detailed Description: Rationale: Salivary gland cancer (SGC) is a rare cancer with 24 histological subtypes. Treatment options for locally advanced and/or metastatic SGC are limited. The tyrosine kinase inhibitor cabozantinib suppresses tumor growth, angiogenesis, and metastasis, and has been approved for renal cell carcinoma and thyroid cancer. Cabozantinib may also be of value in advanced SGC because c-MET, one of the targets of cabozantinib, is frequently overexpressed in SGC. Objectives: To assess the objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DoR), toxicity, and quality of life (QoL) of patients with advanced SGC treated with cabozantinib in 3 cohorts: salivary duct carcinoma (SDC), adenoid cystic carcinoma (ACC), other SGC's. Study design: Single arm, single center, phase II clinical trial in 3 cohorts: ACC, SDC and other SGC's. Study population: Patient with c-MET positive, locally advanced, recurrent, and/or metastatic SGC. Intervention: Cabozantinib tablets 60 mg once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw for a maximum duration of 2 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Radboudumc, Nijmegen, Gelderland, Netherlands
Name: Carla ML van Herpen, MD, PhD
Affiliation: Radboud University Medical Center
Role: PRINCIPAL_INVESTIGATOR