Advanced Solid Tumor Malignancies Clinical Trial
Official title:
A Phase I Study of the CDK4/6 Inhibitor PD-0332991, 5-Fluorouracil, and Oxaliplatin in Patients With Advanced Solid Tumor Malignancies
This study is for patients with advanced solid tumor malignancies (cancer that has spread to
other parts of the body).
The purpose of this study is to test the safety and effectiveness of a new combination of
drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor
malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called
cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this
enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil
and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus
decreasing the tumors in the body.
PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been
approved by the Food and Drug Administration for use in colorectal cancer. It is given as a
pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and
Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved
for and used as chemotherapy for several cancers.
n/a
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