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 range18 Years
SexALL
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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…
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