NCT02885649

Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase 0 trial studies how well enzalutamide works before surgery in treating patients with kidney cancer. Androgens are a type of hormone produced by the body that may cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the amount of androgens produced by the body and keep kidney tumors from growing.

Detailed description

PRIMARY OBJECTIVES: I. To investigate the effects of neoadjuvant enzalutamide on clear cell renal cell carcinoma (ccRCC). OUTLINE: Patients receive enzalutamide orally (PO) daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy. After completion of study treatment, patients are followed up every 3 months.

Conditions

• Clear Cell Renal Cell Carcinoma
• Stage I Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Nephrectomy	Undergo partial or radical nephrectomy

Timeline

• Start date: 2017-12-05
• Primary completion: 2020-03-02
• Completion: 2020-03-02
• First posted: 2016-08-31
• Last updated: 2021-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study