Cabozantinib in Men With Castration-Resistant Prostate Cancer

Status Terminated

Clinical Trial Summary

This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

Primary Outcome Measure:

1. Change in urinary N-telopeptide (uNTX) from baseline to after 6 weeks of treatment with cabozantinib in men with non-metastatic CRPC.

Secondary Outcome Measures:

2. Changes in serum markers of bone metabolism from baseline to after 6 weeks of treatment with cabozantinib. Markers of bone metabolism in blood include bone specific alkaline phosphatase, alkaline phosphatase, LDH.

3. Changes in biomarker expression in bone biopsy samples. To include MET, AKT, FASN and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells. Will also include changes in markers of apoptosis, proliferation, and angiogenesis.

OUTLINE:

Patients receive cabozantinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01703065
Study type	Interventional
Source	University of Washington
Contact
Status	Terminated
Phase	Phase 2
Start date	June 18, 2013
Completion date	September 18, 2015

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