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Spots Global Cancer Trial Database for Cabozantinib in Advanced Salivary Gland Cancer Patients

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Trial Identification

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

Interventions

Cabozantinib

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Radboudumc, Nijmegen, Gelderland, Netherlands

Contact Details

Name: Carla ML van Herpen, MD, PhD

Affiliation: Radboud University Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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