Full TitlePhase I Safety, Pharmacokinetic and Pharmacodynamic Study of PF-02341066, A C-MET/HGFR Selective Tyrosine Kinase Inhibitor, Administered Orally to Patients with Advanced Cancer
The purpose of this study is to determine the highest dose of a new drug called PF-02341066 (crizotinib) that can be given safely to people with advanced cancer. This drug helps stop blood vessels from feeding tumors, causing cancer cells to starve or die. Researchers hope the study will indicate what effect this drug has on patients and their cancer cells. PF-02341066 is taken orally (by mouth).
Researchers also want to see how this drug might work with or against other common drugs. Some patients may receive a drug called midazolam, a sedative used to help with anesthesia. This drug will be given at a low dose and should not have any effect on patients. Midazolam is being used because it is similar to many kinds of drugs that interact with PF-02341066. Researchers will test patients’ blood to see how much of PF-02341066 (or midazolam) stays in the system while taking PF-02341066.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of an advanced cancer (except leukemia) that is not responding to standard therapies or for which no standard therapy exists.
- At least 4 weeks must have passed since completion of prior surgery, radiation therapy, or chemotherapy and entry into the study, and patients must have recovered from any side effects.
- Patients may not have received a prior therapy that targets c-MET/hepatocyte growth factor receptor, the same target as PF-02341066.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.