The efficacy of cabozantinib in advanced salivary gland cancer patients, a phase II clinical trial - Cabo ASAP

Radboud Universitair Medisch Centrum0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月15日

试验速览

Trial is onging in other countries

•In order to be eligible to participate in this study, a patient must meet all of the following criteria:
•- Disease specific
•- locally advanced, recurrent, and/or metastatic SGC (excluding sarcomas and mesenchymal tumors)
•- c-MET positive disease (see paragraph 4.1)
•- 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 albumine *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

•- 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 before randomization. Complete wound healing from major surgery must have occurred 1 month before
•inclusion and from minor surgery at least 10 days before inclusion
•- Uncontrolled illness including, but not limited to
•- Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias
•- Uncontrolled hypertension defined as sustained systolic BP > 150 mm Hg, or diastolic BP > 100 mm Hg
•- Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before inclusion
•- Serious active infections
•- Concomitant treatments
•- Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation.
•- Concurrent treatment with any other anti-cancer therapy.
•- Concomitant anticoagulation.
•- Low dose aspirin for cardioprotection and low dose LMWH are permitted.
•- Radiation therapy within the last 4 weeks before inclusion

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