Cabozantinib in Advanced Salivary Gland Cancer Patients

• Status: Terminated
• Trial end date: 2019-11-06
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2 clinical trial on the efficacy of cabozantinib in locally advanced, recurrent and/or metastatic salivary gland cancer patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Ipsen

Criteria

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 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