Clinical Trials Directory

Trials / Terminated

TerminatedNCT01703065

Cabozantinib in Men With Castration-Resistant Prostate Cancer

A Pilot Study of the Effects of Cabozantinib (XL184) on Bone Turnover and the Microenvironment in Men With Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
9 (actual)
Sponsor
University of Washington · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGCabozantinibGiven orally once a day

Timeline

Start date
2013-06-18
Primary completion
2015-02-02
Completion
2015-09-18
First posted
2012-10-10
Last updated
2018-12-04
Results posted
2018-12-04

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT01703065. Inclusion in this directory is not an endorsement.