cabozantinib for salivary gland cancer patients

Phase 1

• Conditions: Salivary gland cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000682-36-NL
• Lead Sponsor: Radboud university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-16
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 43

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
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

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 clinical trial of medicinal product
• Study Design: Not specified