A phase I study of lenvatinib for unresectable adenoid cystic carcinoma of the salivary gland

Phase 1

• Conditions: Adenoid cystic carcinoma of the salivary gland

• Registration Number: JPRN-UMIN000021080
• Lead Sponsor: Yokohama City University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-18
• Study Completion: 2020-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified