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Metastatic Pancreatic CancerPhase 2NCT03714555

Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine

A Phase 2 study testing Safety Laboratories, AE Assessment and Physical Exam in people with Metastatic Pancreatic Cancer, run by HonorHealth Research Institute 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

This is an open-label Phase 2 Pilot study to evaluate Disulfiram + Copper Gluconate in patients metastatic pancreatic cancer whose CA-19-9 levels rise while receiving nab-paclitaxel (Abraxane) plus gemcitabine (Gemzar) or FOLFIRINOX or single-agent gemcitabine (Gemzar). Read more about this study

Who is it for?
Ages 18 to 105 years
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Safety Laboratories, AE Assessment and Physical Exam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
17 Oct 2019to 29 Jul 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed adenocarcinoma of the pancreas that is metastatic and for which potential curative measures, such as resection of an isolated metastasis, are not available. Patients with islet cell neoplasms are excluded.
  • Patient should currently be receiving a chemotherapy regimen comprising FOLFIRINOX or Abraxane-Gemcitabine or single-agent Gemcitabine as front-line treatment for metastatic disease. Patients who have had chemotherapy in the adjuvant or neoadjuvant setting are eligible.
  • Patients must have previously received a minimum of 8 weeks of therapy with Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine without radiographic evidence of disease progression based on the investigator's opinion, but a rising CA 19-9 level, and still be undergoing treatment with Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine. Increased CA 19-9 is defined as an increased over baseline of > 20% in two consecutive time points within 8 days of each other.
  • Patient has one or more metastatic tumors measurable by CT scan. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
  • Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age.
  • Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100,000/mm3 (100 × 109/L); Hemoglobin (Hgb) ≥ 9 g/dL.
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  • Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0:
  • aspartate aminotransferase (AST) (SGOT), Alanine Transaminase (ALT) (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are present, then ≤ 5 × ULN is allowed. Total bilirubin ≤ 1.5 × ULN.
  • Serum creatinine < 1.5X ULN or estimated creatinine clearance of > 60 mL/min (per Cockroft-Gault formula)
  • Patient has ECOG performance status from 0 to ≤ 1.
  • Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.

Who cannot join

  • Patient has brain metastases.
  • Patient has experienced an increase of ECOG to > 1 between Screening and enrollment.
  • QTc > 480 msec if patient receiving oxaliplatin-containing regimen.
  • Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Patient has a history of allergy or hypersensitivity to any of the study drugs, their pharmaceutical class or any of their excipients. The patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of Gemcitabine or Abraxane ® Prescribing Information package inserts or on the Investigator's Brochure for DSF/Cu.
  • Patient has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or the study data integrity.
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  • Patient is enrolled in any other clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of metastatic pancreatic cancer.
  • Patient is unwilling or unable to comply with study procedures.
  • Abraxane is metabolized by CYP2C8 and CYP3A4. Co-administration of substrates, inhibitors of CYP2C8 (see Appendix C) and/or CYP3A4 (see Appendix D) with Abraxane is not allowed. The following medications and substances are not allowed during the study: ritonavir, saquinavir, indinavir, nelfinavir, rifampicin, carbamazepine, phenytoin, efiravenz, or nerivapine, grapefruit (juice or seeds) or some herbals like St. John's wort.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85251

Other trials in United States

About this study

Official title: A Phase II Pilot Study of Disulfiram and Copper Gluconate in Patients With Metastatic Pancreatic Cancer and Rising CA-19-9 Levels While Receiving Abraxane-Gemcitabine or FOLFIRINOX or Single-Agent Gemcitabine

This is an open-label Phase 2 Pilot study to evaluate Disulfiram + Copper Gluconate in patients metastatic pancreatic cancer whose CA-19-9 levels rise while receiving nab-paclitaxel (Abraxane) plus gemcitabine (Gemzar) or FOLFIRINOX or single-agent gemcitabine (Gemzar). Patient must have received a minimum of 8 weeks of treatment and have rising CA-19-9 levels in the absence of radiographic evidence of progression.

Read the detailed description

This study has 3 arms with 5 patients enrolled in each of the three arms. The three treatment arms are based upon whether the patient has previously received Abraxane-Gemcitabine or FOLFIRINOX or single-agent Gemcitabine without radiographic evidence of disease progression for a minimum of 8 weeks , based on the investigator's opinion, but with a rising Carbohydrate antigen 19-9 (CA 19-9) levels. Rising CA 19-9 is defined as an increased over baseline of > 20% in two consecutive time points within 8 days of each other. Study sites will provide all chemotherapy for patients participating in the study as a "standard of care". DSF/Cu (Disulfiram + Copper Gluconate) will be provided by the Sponsor and shipped from the Sponsor's central depot to the study sites. Sufficient amounts of DSF/Cu will be available at the study site prior to enrolling patients in the study.

Being tested
Safety Laboratories, AE Assessment, Physical Exam, Concomitant Medication Review, Tumor Imaging
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Safety LaboratoriesDiagnostic test

    Complete blood cell count (CBC) w Differential, comprehensive metabolic panel (CMP), Prothrombin time/international normalized ratio (PT/INR) Activated Partial Thromboplastin Time (aPTT), Urinalysis

  • AE AssessmentOther

    Assessment of Adverse Events (AE)

  • Physical ExamOther

    Physical Exam, Weight, Vital Signs, Eastern Cooperative Oncology Group (ECOG) Performance Status

  • Concomitant Medication ReviewOther

    Prior and Concomitant Medication Review

  • Tumor ImagingDiagnostic test

    Tumor CT or MRI

  • nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper GluconateDrug

    nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing

  • FOLFIRINOX regimen Plus Disulfiram/Copper GluconateDrug

    FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing

  • Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper GluconateDrug

    Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing

Study groups in NCT03714555
Study groupRoleWhat they receive
Nab-Paclitaxel/Gemcitabine + DSF/CuActive comparatorSubjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Nab-Paclitaxel-Gemcitabine with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Receives: Diagnostic Test: Safety Laboratories; Other: AE Assessment; Other: Physical Exam; Other: Concomitant Medication Review; Diagnostic Test: Tumor Imaging; Drug: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate; Drug: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate; Drug: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate
FOLFIRINOX +DSF/CuActive comparatorSubjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with FOLFIRINOX and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Receives: Diagnostic Test: Safety Laboratories; Other: AE Assessment; Other: Physical Exam; Other: Concomitant Medication Review; Diagnostic Test: Tumor Imaging; Drug: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate; Drug: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate; Drug: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate
Single-Agent Gemcitabine +DSF/CuActive comparatorSubjects with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of treatment with Single-Agent Gemcitabine and with rising CA 19-9 levels in the absence of radiographic evidence of progression will continue to receive treatment with addition of Disulfiram+Copper Gluconate until disease progression.
Receives: Diagnostic Test: Safety Laboratories; Other: AE Assessment; Other: Physical Exam; Other: Concomitant Medication Review; Diagnostic Test: Tumor Imaging; Drug: nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate; Drug: FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate; Drug: Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate

What is being measured

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

  1. CA19-9 Plasma Level

    Change in plasma CA19-9 level (at least 30%) from baseline

    Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes (9)

  1. Complete Tumor Response

    Complete response rate as defined by CT scan using RECIST 1.1 criteria

    Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  2. Partial Response

    Partial response as defined by CT scan using RECIST 1.1 criteria

    Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  3. Stable Disease

    Complete response as defined by CT scan using RECIST 1.1 criteria

    Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  4. Overall Response Rate

    Overall response rate as defined by CT scan using RECIST 1.1 criteria

    Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  5. Overall Survival

    The length of time from the start of treatment that patients are still alive

    Measured: From date of enrollment until date of death assessed up to 100 months

  6. Serum Albumin

    Change in serum albumin level as a result of treatment

    Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  7. Body Weight

    Change in body weight as a result of treatment

    Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  8. Muscle Area at the L3 Level - Optional

    Change in muscle area at the L3 level using CT scan. Only is L3 is visualized with normally scheduled standard of care CT Scan

    Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  9. Incidence of Toxicities

    Physical exam and laboratory testing will be completed and toxicity grading assessed and documented using CTCAE version 4.0

    Measured: From date of enrollment until the date of follow-up, 30 days after last treatment

Timeline

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

  1. First posted22 Oct 2018
  2. Study start17 Oct 2019
  3. Primary completion22 Jul 2020
  4. Study completion29 Jul 2020

Why it stopped: Study was closed due to low subject enrollment at site.

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03714555
Sponsor's protocol ID
CAN-203
Status last verified
Sep 2023
First submitted
9 Oct 2018
Last updated
18 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Safety Laboratories, AE Assessment and Physical Exam in people with Metastatic Pancreatic Cancer, run by HonorHealth Research Institute 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 11 inclusion and 9 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 18 Oct 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

CA19-9 Plasma Level (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). 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 NCT03714555.

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 18 Oct 2023.

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