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NCT02963051 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer
A Phase 1 study, sponsored by Daniel George, MD.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT02963051 is a Phase 1 study that was terminated before completion, run by Daniel George, MD. The registered enrollment target is 9 participants.
The verdict
NCT02963051, a Phase 1 study, was terminated before completion, sponsored by Daniel George, MD.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
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.
Interventions
- DRUG Disulfiram
- DRUG Copper
- DRUG Copper gluconate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-07-11 |
| Est. Completion | 2020-02-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02963051
The ClinicalTrials.gov registry entry for NCT02963051 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daniel George, MD, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Disulfiram is the first listed.
NCT02963051 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02963051 about?
NCT02963051 is a clinical study titled "A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer". 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 metastas...
What is the current status of trial NCT02963051?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2017-07-11. Estimated completion is 2020-02-01.
What interventions are being tested in trial NCT02963051?
The interventions under investigation include: Disulfiram (DRUG), Copper (DRUG), Copper gluconate (DRUG).
Who is sponsoring clinical trial NCT02963051?
This trial is sponsored by Daniel George, MD, which has 6 total clinical trials registered on ClinicalTrials.gov.
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