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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: Clinical Trial Phase 1 study, sponsored by Daniel George, MD.
NCT02963051 is a Phase 1 study that was terminated before completion, run by Daniel George, MD. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety (NCI CTC v4.0) and tolerability of IV CuCl2 and DSF in men with mCRPC
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 |
Why NCT02963051 stopped before completion
NCT02963051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Disulfiram is the first listed.
NCT02963051 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02963051's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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