NCT01812668

Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

Pilot Trial of Oral Cabozantinib/XL184 in Metastatic Castrate Resistant Prostate Cancer to Explore the Changes in Bone and Tumor Imaging Related Pathways

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the timing, pathophysiology, and magnitude of changes in tumor imaging and pharmacodynamic markers with XL184 (cabozantinib-s-malate) treatment in metastatic castrate resistant prostate cancer. SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) achieved with XL184 in metastatic castrate resistant prostate cancer (CRPC) patients. II. To evaluate the feasibility of the therapy, and the toxicities associated. III. To evaluate overall survival (OS) in metastatic CRPC patients post androgen deprivation therapy (ADT) treated with XL-184. OUTLINE: Patients receive cabozantinib-s-malate orally (PO) daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks and then periodically thereafter.

Conditions

• Adenocarcinoma of the Prostate
• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	cabozantinib-s-malate	Given PO
RADIATION	fluorine F 18 d-FMAU	Undergo 18F PET/FMAU PET scan
PROCEDURE	positron emission tomography	Undergo 18F PET/FMAU PET scan
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-03-01
• Primary completion: 2019-01-18
• Completion: 2019-06-18
• First posted: 2013-03-18
• Last updated: 2021-08-05
• Results posted: 2021-03-23

Locations

1 site across 1 country: United States