Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Study of the HER1, HER2 Dual Kinase Inhibitor, Lapatinib Plus the Proteosomal Inhibitor Bortezomib in Patients With Advanced Malignancies
This study is for patients with an advanced type of cancer for which no curative treatment
exists.
The purpose of this study is to test the safety and efficacy of the combination of the study
drugs, lapatinib and bortezomib. Lapatinib is a drug that targets two proteins important for
the growth of cancer cells known as HER1 (EGFR) and HER2. By inhibiting these proteins,
lapatinib can inhibit cancer cell growth and even lead to their death. Lapatinib is an oral
pill given by mouth once every day. Lapatinib is approved by the FDA for patients with
breast cancer.
Bortezomib is a drug that targets a part of cancer cells known as the proteosome. By
inhibiting the proteosome, bortezomib can inhibit cancer cell growth and even lead to their
death. Bortezomib is given intravenously, once a week, 2 out of every 3 weeks. Bortezomib is
approved by the FDA for patients with multiple myeloma and mantle cell lymphoma.
This research is being done because it is not known if the combination of lapatinib and
bortezomib will work better than lapatinib or bortezomib alone, although in the lab and in
animal studies the combination of the two drugs was much more effective than either drug
alone.
As part of this study biopsies will be taken of patients' tumors before any treatment, after
starting lapatinib alone, and after receiving both lapatinib and bortezomib. Investigators
want to study what markers inside tumors may relate to how well these two medications work.
These biopsies are required as part of the study.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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