Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer
Status:
Completed
Trial end date:
2016-08-21
Target enrollment:
Participant gender:
Summary
Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved
for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or
amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and
protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of
tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium,
germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.
Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both
ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor
may provide improved therapeutic benefit compared with inhibitors that target only one or the
other receptor.
Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients
with HER2-positive refractory cancer.