Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
The aim of the study is to establish clinical evidence for introducing disulfiram and cooper
as an active therapy for metastatic breast cancer upon failure of conventional systemic
and/or locoregional therapies.
Analyses of the following objectives will be performed in the population of patients with
metastatic breast cancer:
Primary efficacy objective:
To evaluate the efficacy of the treatment by assessment of:
- clinical response rate (RR)
- clinical benefit rate (CBR)
Secondary efficacy objectives:
To evaluate the efficacy of the treatment by assessment of:
- time to progression (TTP)
- overall survival (OS)
Pharmacokinetic objectives:
• to determine pharmacokinetic parameters for disulfiram and its active metabolites
administered in combination with copper supplements in cancer patient population
Safety objectives:
• to describe safety profile of disulfiram administered in combination with copper
supplements
Exploratory objectives:
Parallel analysis to assess (identify) potential candidate surrogate biomarkers of disulfiram
efficacy, as well as identification (using proteomic, biochemical and molecular genetic
studies) of potential predictive biomarkers of disulfiram sensitivity or resistance will be
performed. Surrogate biomarker analysis will focus on in vivo ubiquitin-proteosomal system
inhibition, cell cycle and DNA damage.
Phase:
Phase 2
Details
Lead Sponsor:
Marian Hajduch, M.D., Ph.D. The Institute of Molecular and Translational Medicine, Czech Republic