Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases
XL184 will be taken by mouth daily. The first five treatment cycles will be 21 days. All
cycles after that will be 42 days long. Patients will keep a diary to record study drug
During the screening phase patients will receive a physical exam, blood and urine tests, a
bone scan, a CT of the abdomen and pelvis, and an MRI scan of total body. On Day 1 of each
cycle patients will receive a physical exam and blood and urine tests. Bone scan, CT and
MRI scans will be performed at the start of cycles 3 and 5, and then repeated once every 12
Patients will continue to receive study treatment as long as they are receiving benefit from
the treatment, do not experience any severe or unmanageable side effects, and disease does
not get any worse.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Post-Treatment change in bone scan from baseline to week 6
Bone scans will be centrally reviewed and categorized as complete resolution, significant improvement, stable disease, or unequivocal progression based on comparison of week 6 and baseline imaging. An adaptive response design to determine the lowest effective XL184 dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.
Baseline and Week 6
Matthew R Smith, M.D., Ph.D.
Massachusetts General Hospital
United States: Food and Drug Administration
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