NCT02963051

A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Daniel George, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and optimal dosing of intravenous copper chloride and disulfiram in men with metastatic castrate-resistant prostate cancer (CRPC). Eligible men will have neuroendocrine prostate cancer (NEPC), adenocarcinoma CRPC with non-liver/peritoneal metastases (lymph nodes, bone, or lung) or adenocarcinoma CRPC with liver and/or peritoneal metastases. Subjects will receive three doses of intravenous copper chloride and take disulfiram and oral copper gluconate until disease progression (up to two years). Subjects will also undergo a PET scan with radioactive copper 64 to measure the levels of copper in their tumor. The central hypotheses of this project are that (a) copper chloride and disulfiram are safe to give together and that (b) the combination of disulfiram with copper will have efficacy for both mCRPC and NEPC.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Copper	1 mg, 3 mg, 5 mg or 7 mg intravenously on cycle 1 day 1, 8 and 15
DRUG	Disulfiram	80 mg three times a day Source of disulfiram: Cantex Pharmaceuticals
DRUG	Copper gluconate	1.5 mg three times a day Source of copper gluconate: Cantex Pharmaceuticals

Timeline

• Start date: 2017-07-11
• Primary completion: 2018-12-30
• Completion: 2020-02-01
• First posted: 2016-11-15
• Last updated: 2021-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study