Adenoid cystic carcinoma of the salivary gland
Conditions
Interventions
Lenvatinib is administered at a daily dose of 24 mg per day in 28-day cycles. Administration may be reduced or paused when adverse events is seen. Lenvatinib is administrated for 5 cycles maximum. How
Sponsors
Yokohama City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is eligible when he or she has: 1) Histologically or cytologically confirmed adenoid cystic carcinoma of the salivary gland which is local advanced, recurrent or metastatic. Primary sites include parotid gland, submandibular gland, sublingual gland as well as minor salivary gland of oral cavity, nasal cavity, pharynx and larynx. 2) At least one measurable lesion which is diagnosed as progressive disease (PD) according to RECIST version 1.1. 3) No history of treatment with tyrosine kinase inhibitors. Any previous surgical treatment, radiation therapy or chemotherapy is allowed. 4) ECOG Performance status (PS) of 0 or 1. 5) No central nerve system metastasis. 6) Preserved main organ function within 14 days before inclusion. 1. White blood cell count >= 3,000/mm3 2. Neutrophil count >= 1,500/mm3 3. Platelet count >= 100,000/mm3 4. AST <= 100 IU/L 5. ALT <= 100 IU/L 6. T. Bil <= 1.5 mg/dL 7. Serum Creatinine <= 1.2 mg/dL 8. Creatinine clearance >= 60 mL/min 7) Left ventricular ejection fraction (LVEF) >= 50% measured by echocardiogram within 28 days prior to inclusion. 8) No clinically significant abnormality in 12-lead electrocardiogram within 28 days prior to inclusion. 9) Blood pressure <= 150/90 mmHg. 10) Ability of oral intake. 11) Life expectancy of more than 3 months 12) Written, free-will consent with the trial.
Exclusion criteria
Exclusion criteria: Patient is excluded when he or she has: 1) Prior treatment with lenvatinib (E7080). 2) Subjects who have received any anti-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug. 3) Major surgery within 3 weeks prior to the first dose of study drug. 4) Subjects having >1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Subjects with urine protein greater than or equal to 1g/24h will be ineligible. 5) Gastrointestinal malabsorption, or any other condition in the opinion of the investigator that might affect the absorption of lenvatinib (E7080). 6) Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment. 7) Prolongation of QTc interval to >480 msec. 8) Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug. 9) Active infection (any infection requiring treatment). 10) Active malignancy within the past 24 months. 11) Known intolerance to any of study drugs (or any of the excipients). 12) Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial. 13) Female who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety All adverse events will be recorded according to CTCAE version 4.0. Grade 2 or more adverse event will be followed until the event improves to Grade 0 to 1 or beginning of other treatment for cancer, whichever comes first. Severe adverse event (SAE) will be followed and recorded until 90 days after the final administration of the study drug or beginning of other treatment for cancer, whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Progression-free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactHideaki Takahashi
Yokohama City University Otolaryngology-Head and Neck Surgery
Outcome results
None listed