Safety Study of Afatinib for Brain Cancer
NCT02423525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2022-03-10
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).
Conditions
Interventions
- DRUG
-
Afatinib
Sponsors & Collaborators
- collaborator INDUSTRY
-
Santosh Kesari
lead OTHER
Principal Investigators
-
Santosh Kesari, MD, PhD · Saint John's Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-31
- Primary Completion
- 2020-08-31
- Completion
- 2021-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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