Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma (NCT NCT03034135)

NCT ID: NCT03034135

Last Updated: 2021-09-13

Results Overview

ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-09-13

Participant Flow

Participant milestones

Measure	DSF-Cu Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	DSF-Cu Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Disulfiram and Copper Gluconate n=23 Participants Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.

Outcome measures

Measure	DSF-Cu n=21 Participants Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care
Objective Response Rate Complete response	0 Participants
Objective Response Rate Partial Response	0 Participants

SECONDARY outcome

Timeframe: 6 months

Percentage of patients that are free from progressive disease per RANO criteria

Outcome measures

Measure	DSF-Cu n=21 Participants Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care
Progression Free Survival	14 percentage of participants Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 6 months and 12 months

Percentage of patients that are alive

Outcome measures

Measure	DSF-Cu n=21 Participants Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care
Overall Survival 6 months	61 percentage of participants Interval 41.0 to 81.0
Overall Survival 12 months	35 percentage of participants Interval 15.0 to 54.0

SECONDARY outcome

Timeframe: 14 months

Number of Participants with Grade 3 and 4 serious adverse events

Outcome measures

Measure	DSF-Cu n=23 Participants Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care
Number of Participants With Serious Adverse Events	2 Participants

SECONDARY outcome

Timeframe: 12 months

Duration of progression free survival according to RANO criteria

Outcome measures

Measure	DSF-Cu n=21 Participants Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care
Median Progression Free Survival	1.7 months Interval 1.4 to 1.9

SECONDARY outcome

Timeframe: 14 months

Duration of overall survival for patients that are alive

Outcome measures

Measure	DSF-Cu n=21 Participants Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months. Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day. Temozolomide (TMZ): TMZ is given per standard of care
Median Duration of Overall Survival	7.1 months Interval 5.8 to 8.5

Adverse Events

Group A

Serious events: 2 serious events

Other events: 0 other events

Deaths: 14 deaths

Serious adverse events

Measure	Group A n=23 participants at risk Eligible patients must have progressed after standard chemoradiotherapy and within 3 months of the last dose of TMZ.
Hepatobiliary disorders Hepatobiliary disorders	4.3% 1/23 • Number of events 1 • 14 months
General disorders Fatigue	4.3% 1/23 • Number of events 1 • 14 months

Other adverse events

Adverse event data not reported

Additional Information

Stephen Marcus MD

Cantex Pharmaceuticals

Phone: 9543153660

Email: smarcus@cantex.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place