Phase II Trial of Cabozantinib (XL184) in Patients With Advanced Solid (Non-breast, Non-prostate) Malignancies and Bony Metastases
Cabozantinib is a tablet that the subject will take by mouth. The subject will take it once
per day. The study treatment with cabozantinib will be divided into 28 day cycles. A member
of the study staff will give the subject a drug diary and explain to the subject how to use
it to record doses of cabozantinib. This diary will also contain specific instructions about
how the subject take cabozantinib.
Every 28 days the subject will undergo the following procedures: Physical examination,
questions about any side effects the subject may have, blood samples for routine laboratory
tests and research tests, urine sample, electrocardiogram (EKG), and questionnaires to
measure quality of life and level of pain. Every two months the subject will undergo a CT
scan or MRI to evaluate the subjects disease.
The investigators would like the subject to return to the study clinic for follow-up
procedures about 4-5 weeks after the last dose of cabozantinib.
The subject can continue to receive the study drug for as long as their disease does not
worsen and the subject do not experience unacceptable side effects.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of Cabozantinib on Bone Biomarkers
Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast acitivity (urinary NTx, serum NTx, serum CTx, among others)
Rebecca Heist, MD
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|