Cabozantinib in Advanced Salivary Gland Cancer Patients (NCT03729297) | Clinical Trial Compass
TerminatedPhase 2
Cabozantinib in Advanced Salivary Gland Cancer Patients
Stopped: safety issues
Netherlands25 participantsStarted 2018-09-05
Plain-language summary
Phase 2 clinical trial on the efficacy of cabozantinib in locally advanced, recurrent and/or metastatic salivary gland cancer patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Disease specific
* locally advanced, recurrent, and/or metastatic SGC (excluding sarcomas and mesenchymal tumors)
* c-MET positive disease
* Measurable disease per RECIST version 1.1 Cohort-specific criteria
* SDC cohort: direct inclusion (no objective tumor growth prior to inclusion needed)
* ACC cohort: inclusion after objective growth in the last three months or complaints due to the disease
* Other SGC's: inclusion after objective growth in the last three months or complaints due to the disease General conditions
* Age ≥18 years
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Normal number of neutrophils and thrombocytes
* Liver function: ALT and AST \< 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN (except for Gilbert's syndrome), serum albumin ≥28 g/L
* Renal function: creatinine \< 1.5 x ULN or calculated creatinine clearance ≥ 40 ml/min, Urine protein/creatinine ratio ≤113.1 mg/mmol (≤1 mg/mg) or 24-hour urine protein \<1 g
* Hemoglobin A1c (HbA1c) ≤ 8% or a fasting serum glucose ≤ 9 mmol/l
Exclusion Criteria:
General conditions
* A known allergy for cabozantinib or its components
* Long QT-syndrome
* Pregnancy or lactation
* Patients (M/F) with reproductive potential not implementing adequate contraceptives measures
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before inclusion
* Major surgery within 3 months…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
overall response rate
Timeframe: 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