Brain Cancer Clinical Trial
Official title:
A Phase II Study to Evaluate the Efficacy, Safety, and Central Nervous System (CNS) Pharmacokinetics of the HER Family Inhibitor Dacomitinib in Progressive Brain Metastases
The purpose of this study is to determine the disease response, survival, and side effects of an experimental drug called dacomitinib in progressive brain metastases.
The purpose of this study is to investigate the use of the irreversible pan-ErB kinase
inhibitor dacomitinib in the treatment of brain metastases, as measured by radiographic
objective response rate.
The rationale of this study is three-fold. First, the use of dacomitinib, an irreversible
pan-ErB kinase inhibitor, is to improve the duration of response seen by reversible, EGFR
only inhibitors. Inhibition of the multiple ErB kinases may interfere with receptor
cross-talk as a method of developing resistance; indeed, patients who have failed erlotinib
treatment for systemic disease have seen responses to dacomitinib. The second rationale is
to evaluate the pharmacokinetics of the penetration of dacomitinib into the CSF to determine
if adequate drug levels reach the CNS, and determine if the current dosing regimen is
appropriate. The third rationale is to determine if specific molecular phenotypes
preferentially respond to dacomitinib. As part of this study, serum and cerebrospinal fluid
will be collected and analyzed both for drug levels and for molecular markers to key
elements of the ErB signaling cascade. The objective of the marker analysis to identify a
distinct molecular phenotype that may preferentially respond to targeted drug therapy in the
future.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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