NCT04296578

Study Evaluating Sodium Selenite in Combination With Abiraterone in Castrate Resistant Prostate Cancer Progressing on Abiraterone

A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to access the safety of combining sodium selenite with abiraterone and to see what doses of sodium selenite can be safely combined with abiraterone in treating castration resistant prostate cancer.

Detailed description

PRIMARY OBJECTIVE(S): · To determine the maximum tolerated dose (MTD) of sodium selenite when given in combination with abiraterone. SECONDARY OBJECTIVE(S): * To assess the safety and tolerability of the combination of sodium selenite and abiraterone in subjects with castration resistant prostate cancer (CRPC) * To assess the pharmacokinetics of sodium selenite * To assess changes in Prostate specific antigen (PSA) To evaluate the anti tumor activity of sodium selenite and abiraterone when given in combination as determined by biochemical progression free survival (PFS) and radiographic PFS.

Conditions

• Prostate Cancer
• Castrate Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Standard of Care (SOC) abiraterone (Zytiga) as per package insert. The recommended dose of ZYTIGA is 1,000 mg (four 250 mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally twice daily.
DRUG	Sodium Selenite	11 mg tablets
DRUG	Prednisone	SOC prednisone 5 mg PO twice daily

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-01
• Completion: 2023-10-01
• First posted: 2020-03-05
• Last updated: 2021-08-12

Regulatory

• FDA-regulated drug study