A Phase 2 interventional study of Cabozantinib in Salivary Gland Cancer, sponsored by Radboud University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-12.
Sponsored by Radboud University Medical Center · Phase 2, Interventional, and Treatment
Phase 2 clinical trial on the efficacy of cabozantinib in locally advanced, recurrent and/or metastatic salivary gland cancer patients.
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.
156 studies on the registry are indexed under Salivary Gland Neoplasms; 29 are open to participants now.
This study's enrollment of 25 is below the median of 36 across 133 interventional studies indexed under Salivary Gland Neoplasms.
Browse Salivary Gland Neoplasms studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Disease specific
Exclusion Criteria:
General conditions
cabozantinib 60 mg tablets OD
Drug: Cabozantinib
cabozantinib tablets (Cabometyx®) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw for a maximum duration of 2 years.
Also known as: cabometyx
overall response rate
Response will be measured according to RECIST version 1.1, the overall response rate is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient
Time frame: every 8 weeks (first year of treatment) and every 12 weeks (second year of treatment) a CT/MRI scan will be made to asses the response rate until progressive disease
progression free survival
progression free survival is defined as time from study enrollment until disease progression or death. Outcome will be scored as 'progressed' or 'censored' according to the FDA guidance for industry of clinical trial endpoints.
Time frame: every 8 weeks (first year of treatment) and every 12 weeks (second year of treatment) a CT/MRI scan will be made to asses PFS until progressive disease
overall survival
overall survival is defined as time from study enrollment until date of death of any cause. Analysis of OS will be done at the end of the study (study related follow-up will be until 3 years after start of treatment)
Time frame: Every OPD visit (starting with every 2 weeks, increasing to every 12 weeks after 1 year)
duration of response
duration of response is defined as time from study enrollment until date of documented tumor progression or death. Only patients with a CR or PR will be included in the assessment of duration of response.
Time frame: every 8 weeks (first year of treatment) and every 12 weeks (second year of treatment) a CT/MRI scan will be made to asses duration of response until progressive disease
clinical benefit rate
defined as the sum of complete remissions, partial responses, and patients with stable disease for \>6 months.
Time frame: every 8 weeks (first year of treatment) and every 12 weeks (second year of treatment) a CT/MRI scan will be made to asses the clinical benefit rate until progressive disease
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
adverse events will be reported as descriptive statistics in a table
Time frame: through study completion. At every visit AE's will be recorded. Scheduled visits will be planned 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92 and 104 weeks after start of treatment
quality of life based on the EORTC QLQ-C30 questionnaire
Time frame: patients are asked to fill in the questionnaires in week 0 (before start of treatment), week 8, 16, 24, 40, 56, and at progressive disease (up to 104 weeks after start of study medication).
quality of life based on the EORTC QLQ-H&N35 questionnaire
Time frame: patients are asked to fill in the questionnaires in week 0 (before start of treatment), week 8, 16, 24, 40, 56, and at progressive disease (up to 104 weeks after start of study medication).
quality of life based on the PSSHN questionnaire
Time frame: patients are asked to fill in the questionnaire in week 0 (before start of treatment), week 8, 16, 24, 40, 56, and at progressive disease (up to 104 weeks after start of study medication)..
pain level assessed by the VAS(visual analog scale) questionnaire
scale range 0-10, in which a higher score represents more pain
Time frame: patients are asked to fill in the questionnaire in week 0 (before start of treatment), week 8, 16, 24, 40, 56, and at progressive disease (up to 104 weeks after start of study medication).
response rate with continues tumor shrinkage end-points
response rate depicted in a waterfall plot
Time frame: every 8 weeks (first year of treatment) and every 12 weeks (second year of treatment) a CT/MRI scan will be made to asses the response rate until progressive disease
circulating tumor DNA levels
circulating tumor DNA levels will be assessed to evaluate whether treatment response and disease progression can be predicted.
Time frame: circulating tumor DNA levels will be measured at baseline, at week 2, week 4 and before every evaluation CT/MRI scan.
correlation of c-MET immunohistochemical score with treatment response
c-MET immunohistochemical score ranges from 0 to 300.
Time frame: c-MET will be measured once (before treatment). Response will be measured every 8 weeks (first year) and every 12 weeks (second year of treatment)
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Plan to share: No
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Radboud University Medical Center