drugset
drugset / Trial / NCT02963051

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

NCT02963051 ↗

Phase 1 Terminated 9 enrolled Daniel George, MD Cantex Pharmaceuticals · collabGive 1 For Dad Campaign · collabPeter Michael Foundation · collabThe V Foundation for Cancer Research · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-07-11
Primary completion
2018-12-30
Completion
2020-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Copper Unknown 1 mg Intravenous
Subject Copper Unknown 3 mg Intravenous
Subject Copper Unknown 5 mg Intravenous
Subject Copper Unknown 7 mg Intravenous
Subject Disulfiram Small molecule 80 mg Oral
Background Copper Gluconate Small molecule 1.5 mg Oral

Indications

prostate cancer