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Brief Title: Trial of Cabozantinib (XL184) in Castrate-Resistant Prostate Cancer Metastatic to Bone
Official Title: A Phase II Trial of Cabozantinib (XL184) in Patients With Castrate-Resistant Prostate Cancer Metastatic to Bone
Study ID: NCT01428219
Brief Summary: The purpose of this study is to look at the effects of cabozantinib on castrate-resistant prostate cancer metastatic (cancer that has spread to other parts of the body) to the bone and to learn about any side effects caused by taking cabozantinib.
Detailed Description: A significant proportion of patients with prostate cancer develop metastatic disease, which most commonly affects the skeleton. Bone metastases are the cause of significant morbidity and mortality in these patients, and require long-term management. Study participants in this research study will have a diagnosis of castration-resistant prostate cancer metastatic to bone. Cabozantinib is not approved by the United States Food and Drug Administration (FDA) to treat people for castration-resistant prostate cancer metastatic to bone or for any other type of cancer. Giving cabozantinib to human cancer patients is experimental. Cabozantinib is currently being given to patients on other studies. Cabozantinib is known to have anti-tumor effects and to reduce bone metastases based on early clinical studies in prostate cancer and other cancers. The drug is known to have side effects. The most common side effects were fatigue, diarrhea, anorexia, rash, and palmar-plantar erythrodysesthesia (PPE) syndrome. To date, it is not known if cabozantinib is safe and/or effective.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
University of Michigan, Ann Arbor, Michigan, United States
Name: David C. Smith, M.D.
Affiliation: University of Michigan
Role: PRINCIPAL_INVESTIGATOR