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

Phase 2

Completed

Conditions: salivary gland cancer
10027476

Registration Number: NL-OMON46770

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

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

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 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the objective response rate (ORR)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the progression free survival (PFS), overall survival (OS), duration<br /><br>of response (DoR), toxicity, and quality of life (QoL) of patients with<br /><br>advanced SGC treated with cabozantinib in 3 cohorts: salivary duct carcinoma<br /><br>(SDC), adenoid cystic carcinoma (ACC), other SGC*s.</p><br>