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

NCT03714555 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-10-18

Study results available
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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). 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.

Conditions

Interventions

DIAGNOSTIC_TEST

Safety Laboratories

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

OTHER

AE Assessment

Assessment of Adverse Events (AE)

OTHER

Physical Exam

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

OTHER

Concomitant Medication Review

Prior and Concomitant Medication Review

DIAGNOSTIC_TEST

Tumor Imaging

Tumor CT or MRI

DRUG

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

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

DRUG

FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate

FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing

DRUG

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

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

Sponsors & Collaborators

  • Cantex Pharmaceuticals

    collaborator INDUSTRY

  • HonorHealth Research Institute

    lead OTHER

Principal Investigators

  • Gayle Jameson, ACNP-BC · HonorHealth Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2020-07-22
Completion
2020-07-29
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 NCT03714555 on ClinicalTrials.gov