This research study is a PHase II clinical trial, which tests the safety and effectiveness of
an investigational combination of drugs to learn whether the combination of drugs works in
treating a specific cancer. "Investigational" means that the combination of drugs is being
studied. It also means that the FDA has not yet approved these drugs or combination of drugs
for use in participants, including people with your type of cancer.
Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood
supply so that it does not get the blood and nutrients it needs to grow. This drug has been
used in other research studies and information from those other research studies suggests
that this drug may help to slow the growth of cancer cells.
Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of
pancreatic cancer and several other cancers. It is not approved for the treatment of renal
cell carcinoma. Previous research suggests combining gemcitabine with tivozanib may have some
effectiveness in treating metastatic renal cell carcinoma.
The purpose of this research study is to determine the effectiveness of tivozanib as a
treatment for renal cell carcinoma. The purpose of this research study is to also determine
if the combination of tivozanib and gemcitabine is effective in treating your type of cancer
if your cancer becomes unresponsive or gets worse with tivozanib as treatment alone. The
safety of the combination of tivozanib and gemcitabine will also wbe studied.
Another goal of this research study is to learn more about how tivozanib alone and the
combination of tivozanib and gemcitabine may work to treat renal cell carcinoma. During the
research study we will perform blood tests to measure the level of substances in the blood
such as proteins (biomarkers) that may predict who will respond to treatment with tivozanib
and gemcitabine.