Repurposing disulfiram as treatment for metastatic colorectal cancerAn investigator initiated clinical phase II trial

Phase 1

• Conditions: Metastatic, non-resectable and irinotecan-resistant colorectal cancer; MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002748-25-DK
• Lead Sponsor: Department of Oncology, Odense Universitetshospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

--Age = 18 years.
-Histologically verified colorectal adenocarcinoma.
-Non-resectable mCRC.
-Measurable or no-measurable disease according to RECIST version 1.1.
-Performance status (WHO) of 0-1 and a life expectancy > 3 months.
-Documented early* progressive disease following at least 2months of irinotecan (+/-fluoropyrimidines). **on treatment or within 6 mons after ended treatment.
-Adequate haematological function defined as neutrophils ? 1.5 x 109/l and platelets = 100 x 109/l.
-Adequate organ function (normal bilirubin, GFR (may be calculated) > 60 ml/min).
-Willingness to refrain from alcohol consumption of alcohol during the trial and 14 days after the last treatment with Disulfiram.
-Woman of childbearing potential must have been tested negative in a serum pregnancy test within 5 days prior to randomisation. Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control. (i.e., pregnancy rate of less than 1 % per year) during the study and for 6 months after the discontinuation of study medication.
-Has provided written informed consent prior to performance of any study procedure.
-Written informed consent must be obtained according to the local Ethics Committee requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

-Known UGT-1A1 polymorphism.
-Known CNS metastases
-Prior history of cancer, except cervix in situ carcinoma, in situ urothelial carcinoma or previously treated and cured skin basocellular, and any other cancer in complete remission for at least 2 years.
-Uncontrolled hypertension (systolic blood pressure > 169 mmHg or diastolic blood pressure > 100 mmHg)
-Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives (e.g. known CNS metastasis; infection; drainage of ascites or pleural effusion within 4 weeks; intestinal obstruction; uncontrolled diabetes; AMI within 12 months; severe/unstable angina; known HIV or hepatitis B or C; major surgery within 4 weeks; uncontrolled hypertension).
-Known allergy or intolerance to any of the drugs used (irinotecan, disulfiram, and copper).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified