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Prostate CancerPhase 1NCT02963051

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

A Phase 1 study testing Copper, Disulfiram and Copper gluconate in people with Prostate Cancer, run by Daniel George, MD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Copper, Disulfiram and Copper gluconate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
11 Jul 2017to 1 Feb 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Karnofsky performance status ≥ 70
  • Life expectancy of ≥ 12 weeks as determined by treating investigator
  • Adequate laboratory parameters
  • Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 80 x 109/L, Hb>9 g/dL
  • AST/SGOT and ALT/SGPT ≤ 2.5 x Institutional Upper Limit of Normal (ULN)
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  • Serum bilirubin ≤ 1.5 x Institutional ULN
  • Serum creatinine ≤ 1.5 x Institutional ULN or 24-hour clearance ≥ 50 mL/min
  • Histologically confirmed diagnosis of prostate cancer. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are included.If neuroendocrine prostate cancer is not biopsy proven, clinical evidence of neuroendocrine prostate cancer is acceptable for stratification into group A.
  • Radiographic evidence of metastatic disease.
  • Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed. OR Screening serum testosterone must be <50 ng/dl.
  • Evidence of disease progression on ADT as evidenced by one of the following:
  • 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR
  • CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to PCWG3 criteria or RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies, OR
  • Absolute rise in PSA of 2.0ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level
  • A minimum of 2 weeks elapsed off of antiandrogen therapy prior to registration (i.e. flutamide, nilutamide, and bicalutamide) without evidence of an anti-androgen withdrawal response. An anti-androgen withdrawal response is a PSA level at 2 weeks (or more) off of anti-androgen equal or higher than PSA level when anti-androgen therapy stopped.
  • For subjects in Groups B or C, previous use of at least one androgen pathway inhibitor (either abiraterone acetate or enzalutamide) for metastatic CRPC
  • For subjects in Group A with NEPC, previous use of at least one platinum-containing chemotherapy regimen.
  • A minimum of 2 weeks off of enzalutamide or abiraterone if applicable, prior to registration.
  • A minimum of 4 weeks from prior chemotherapy, including but not limited to, docetaxel, cabazitaxel, mitoxantrone, carboplatinum, cisplatin, or estramustine; if applicable, prior to registration.
  • A minimum of 4 weeks from any major surgery prior to registration.
  • Ability to swallow, retain, and absorb oral medication.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Willingness to abstain from alcohol or any alcohol-containing fluids for the duration of the study.

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from the study:
  • Symptomatic subjects who accept treatment with approved palliative or life-prolonging systemic therapies, including docetaxel and cabazitaxel chemotherapy. (Note: subjects who refuse chemotherapy or are not symptomatic or in immediate need for standard systemic therapies may be included.)
  • Known history of Wilson's disease or a copper deficiency.
  • Uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP > 95 mmHg) or other medical condition that could jeopardize the assessment of toxicity on study.
  • Active or symptomatic viral hepatitis or chronic liver disease.
  • Known history of Hepatitis B Virus (HBV) or Hepatitis C (HCV) infection.
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  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline.
  • Symptomatic atrial fibrillation or other cardiac arrhythmia for which the therapy is not stable or requiring changes in therapy within 1 month of treatment initiation. Atrial fibrillation or other cardiac arrhythmia which is clinically stable on stable therapy is allowed.
  • Corrected QT interval calculated by the Bazett formula (QTcB) >480 msec.
  • Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of death within 24 months.
  • Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1.
  • Any condition which, in the opinion of the investigator, would preclude participation in this trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

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
Being tested
Copper, Disulfiram, Copper gluconate
Keywords
metastatic castrate-resistant prostate cancer (mCRPC), neuroendocrine prostate cancer (NEPC), adenocarcinoma castrate-resistant prostate cancer (CRPC), Copper, Disulfiram
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CopperDrug

    Also called Copper chloride

    1 mg, 3 mg, 5 mg or 7 mg intravenously on cycle 1 day 1, 8 and 15

  • DisulfiramDrug

    Also called Anatabuse

    80 mg three times a day

    Source of disulfiram: Cantex Pharmaceuticals

  • Copper gluconateDrug

    1.5 mg three times a day

    Source of copper gluconate: Cantex Pharmaceuticals

Study groups in NCT02963051
Study groupRoleWhat they receive
Neuroendocrine prostate cancer (NEPC)ExperimentalSubjects with neuroendocrine prostate cancer (NEPC) Copper will be administered intravenously at a dose of 1, 3, 5, or 7 mg on cycle 1 days 1, 8, 15. Disulfiram will administered orally at a dose of 80 mg three times a day starting on cycle 1 day 2. Copper gluconate will be administered orally at a dose of 1.5 mg three times a day starting on cycle 1 day 16.
Receives: Drug: Copper; Drug: Disulfiram; Drug: Copper gluconate
Adenocarcinoma CRPC with non-liver/peritoneal metastasesExperimentalSubjects with adenocarcinoma CRPC with non-liver/peritoneal metastases (lymph nodes, bone, or lung) Copper will be administered intravenously at a dose of 1, 3, 5, or 7 mg on cycle 1 days 1, 8, 15. Disulfiram will administered orally at a dose of 80 mg three times a day starting on cycle 1 day 2. Copper gluconate will be administered orally at a dose of 1.5 mg three times a day starting on cycle 1 day 16.
Receives: Drug: Copper; Drug: Disulfiram; Drug: Copper gluconate
Adenocarcinoma CRPC with liver and/or peritoneal metsExperimentalSubjects with adenocarcinoma CRPC with liver and/or peritoneal metastases Copper will be administered intravenously at a dose of 1, 3, 5, or 7 mg on cycle 1 days 1, 8, 15. Disulfiram will administered orally at a dose of 80 mg three times a day starting on cycle 1 day 2. Copper gluconate will be administered orally at a dose of 1.5 mg three times a day starting on cycle 1 day 16.
Receives: Drug: Copper; Drug: Disulfiram; Drug: Copper gluconate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events

    Safety (NCI CTC v4.0) and tolerability of IV CuCl2 and DSF in men with mCRPC

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Median radiographic progression free survival (PFS)

    Radiographic PFS based on PCWG3 criteria or based on the onset of a skeletal related event. Imaging obtained every 12 weeks.

    Measured: Every 12 weeks, up to 2 years

  2. Amount of 64-Copper uptake by the tumor

    64-Copper PET imaging

    Measured: Baseline

  3. Change in PSA

    PSA response

    Measured: Every 4 weeks, up to 2 years

  4. Time to PSA nadir

    Time to PSA nadir

    Measured: Every 4 weeks, up to 2 years

  5. Time to PSA progression

    Time to PSA progression

    Measured: Every 4 weeks, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2016 (estimated)
  2. Study start11 Jul 2017
  3. Primary completion30 Dec 2018
  4. Study completion1 Feb 2020

Why it stopped: Study stopped due to lack of efficacy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02963051
Sponsor's protocol ID
Pro00071007
Status last verified
Sep 2021
First submitted
10 Nov 2016
Last updated
16 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Copper, Disulfiram and Copper gluconate in people with Prostate Cancer, run by Daniel George, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study stopped due to lack of efficacy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02963051.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.

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