NCT03034135

Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma

A Phase II, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of DIsulfiram and Copper Gluconate in Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Cantex Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their routine standard of care with TMZ therapy for approximately 6 months. Patients will be evaluated for response every 8 weeks. Patients will be followed up 2 years after the last dose of DSF-Cu.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Disulfiram/Copper	Disulfiram/copper gluconate is taken three times a day.
DRUG	Temozolomide (TMZ)	TMZ is given per standard of care

Timeline

• Start date: 2017-03-09
• Primary completion: 2018-07-10
• Completion: 2018-07-10
• First posted: 2017-01-27
• Last updated: 2021-09-13
• Results posted: 2021-09-13

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study