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

Radboud university medical center0 个研究点目标入组 43 人开始时间: 2018年5月16日最近更新: 2020年11月3日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 28
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•- 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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