drugset / Trial / NCT02423525

Safety Study of Afatinib for Brain Cancer

NCT02423525

Phase 1 Completed 24 enrolled Santosh Kesari Boehringer Ingelheim · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to try to determine the maximum safe dose of afatinib that can be administered to people with brain cancer. Other purposes of this study are to: * find out what effects (good and bad) afatinib has; * see how much drug gets into the body by collecting blood and cerebrospinal fluid for use in pharmacokinetic (PK) studies; * learn more about how afatinib might affect the growth of cancer cells; * look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug).

Timeline

Start
2016-12
Primary completion
2020-08
Completion
2021-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 80 mg Oral
Subject Afatinib Small molecule 120 mg Oral
Subject Afatinib Small molecule 180 mg Oral
Subject Afatinib Small molecule 280 mg Oral

Indications