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Cabozantinib in CRPC

NCT01703065Phase 2

Key facts

Status: Terminated
Start: Jun 2013
Primary completion: Feb 2015
Countries: 1
Sponsor: University of Washington
Modality: Small Molecules

Drugs: cabozantinib
Conditions: castration-resistant prostate cancer (CRPC)

Overview

Phase 2, open-label trial of cabozantinib in castration-resistant prostate cancer (CRPC) (2 arms), sponsored by University of Washington. Primary endpoint: Change in Urinary N-telopeptide at 6 weeks. Started Jun 2013; status: terminated.

Design

2 arms

Study design: Non-randomizedOpen-label

Cabozantinib in metastatic CRPC
Metastatic CRPC patients receive cabozantinib PO QD
Cabozantinib in non-metastatic CRPC
Non-Metastatic CRPC patients receive cabozantinib PO QD

Endpoints

Primary

Change in Urinary N-telopeptide6 weeks

Secondary

Change in Bone Specific Alkaline Phosphatase6 weeks
Change in Alkaline Phosphatase6 weeks
Change in Lactic Acid Dehydrogenase6 weeks
Changes in Biomarker Expression in Bone Biopsy Samples6 weeks

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