Study of new compounds in the treatment of brain tumors: drug levels and signs of effect inside the tumor tissue (INSIDE)

Drug level and Investigation of Novel Substances Indicated Downstream Effect in (INSIDE) glioblastoma - INSIDE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004471-46-SE

Enrollment

Registered

2017-01-11

Start date

2017-11-14

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma MedDRA version: 19.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Antabus Pharmaceutical Form: Effervescent tablet INN or Proposed INN: DISULFIRAM CAS Number: 97-77-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A suspected glioblastoma (based on MRI) or recurrent glioblastoma undergoing surgical resection. 2. Elective surgical indication. 3. Age 18 years or older. 4. Karnofsky performance status of 60 – 100. 5. Not receiving another experimental treatment for glioblastoma at the moment of inclusion. 6. Able to take oral medications. 7. No known allergy to substance. 8. Absolute neutrophil count = 1,500/mcL and platelets = 100,000/mcL. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Other likely diagnosis than glioblastoma based on MRI. 2. Pregnant and/or breastfeeding. 3. Women of childbearing potential who do not have a negative pregnancy test (not older than 14 days) before inclusion. 4. History of active liver disease, including chronic active hepatitis, viral hepatitis (hepatitis B, C and CMV), cholestatic jaundice of any etiology or toxic hepatitis or inadequate hepatic function, defined as baseline ASAT and ALAT > 1.5 X upper institutional limit and/or bilirubin > 1.5 X upper institutional limit. 5. Suspected significant raised intracranial pressure or other indication for emergent surgery. 6. Unfit for participation for any other reason judged by the including physician. 7. Unfit for participation due to any substance specific contraindications

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate tissue levels and target effect of : a) disulfiram with copper-supplement and b) metformin;Secondary Objective: Not applicable;Primary end point(s): To assess concentrations and target effects of the study drugs. ;Timepoint(s) of evaluation of this end point: At visit 3, during surgery	—

Secondary

Measure	Time frame
Secondary end point(s): Events of toxicity/safety occurring from inclusion to 14-21 days postoperatively will be reported according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 ;Timepoint(s) of evaluation of this end point: As specified in E.5.2	—

Countries

Sweden

Contacts

Public ContactKlara Thorsson

Gothia Forum

klara.thorsson@vgregion.se+46700822565

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026