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

NCT02963051 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-09-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Give 1 For Dad Campaign

    collaborator UNKNOWN

  • The V Foundation for Cancer Research

    collaborator OTHER

  • Peter Michael Foundation

    collaborator UNKNOWN

  • Cantex Pharmaceuticals

    collaborator INDUSTRY

  • Daniel George, MD

    lead OTHER

Principal Investigators

  • Daniel George, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2018-12-30
Completion
2020-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02963051 on ClinicalTrials.gov