Spots Global Cancer Trial Database for Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC
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Trial Identification
Brief Title: Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC
Official Title: A Dose Finding Study of Continuous and Intermittent High-dose (HDI) Afatinib (EGFR TKI) on CNS Metastases and Leptomeningeal Disease (LMD) in Patients With Advanced Refractory EGFR Mutation Positive Non-small Cell Lung Cancer
Study ID: NCT03711422
Study Description
Brief Summary: Brain metastases occurs in up to 50% of patients with EGFR mutant NSCLC. Leptomeningeal disease is a subset of patients with brain metastases for which there remains an unmet need. This trial aims to evaluate the role of two dosing schedules of afatinib in management of leptomeningeal disease in EGFR mutant NSCLC, specifically to determine Central Nervous System (CNS) penetration of afatinib, as well as clinical activity. Patients will start on daily dosing initially followed by pulsed intermittent dosing should we observe no clinical activity. A secondary objective is to identify the resistance spectrum in leptomeningeal disease. It is anticipated that optimal dosing schedule of afatinib e.g. pulsed dosing may improve CNS disease control.
Detailed Description:
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Center Singapore, Singapore, , Singapore
Contact Details
Name: Daniel SW Tan, MD
Affiliation: National Cancer Centre, Singapore
Role: PRINCIPAL_INVESTIGATOR
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