A Phase II Trial of Cabozantinib (XL184) in Patients With Castrate-Resistant Prostate Cancer Metastatic to Bone
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of cabozantinib in patients with castrate-resistant prostate cancer metastatic to bone.
Efficacy will be measured by the proportion of participants who remain progression-free at 12 weeks after initiation of the study.
12 weeks after participant initiates study
David C. Smith, M.D.
University of Michigan
United States: Food and Drug Administration
|University of Michigan||Ann Arbor, Michigan 48109-0624|