Trial Outcomes & Findings for Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane (NCT NCT03930680)

NCT ID: NCT03930680

Last Updated: 2025-07-08

Results Overview

Number of participants with 95% reduction in topoisomerase 2 b from baseline is reported in the Outcome Measure Data Table

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 25 participants
• Primary outcome timeframe: 8 hours after dexrazoxane administration
• Results posted on: 2025-07-08

Participant Flow

Participant milestones

Measure	Dexrazoxane 100mg/m2 one dose of 100mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 200mg/m2 one dose of 200mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 300mg/m2 one dose of 300mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 400mg/m2 one dose of 400mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 500mg/m2 one dose of 500 mg/m2 Dexrazoxane: One dose of dexrazoxane
Overall Study STARTED	5	5	5	5	5
Overall Study COMPLETED	5	5	5	5	5
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane

Baseline characteristics by cohort

Measure	Dexrazoxane 100mg/m2 n=5 Participants one dose of 100mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 200mg/m2 n=5 Participants one dose of 200mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 300mg/m2 n=5 Participants one dose of 300mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 400mg/m2 n=5 Participants one dose of 400mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 500mg/m2 n=5 Participants one dose of 500 mg/m2 Dexrazoxane: One dose of dexrazoxane	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	25 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	25 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	19 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	5 participants n=21 Participants	25 participants n=8 Participants

PRIMARY outcome

Timeframe: 8 hours after dexrazoxane administration

Number of participants with 95% reduction in topoisomerase 2 b from baseline is reported in the Outcome Measure Data Table

Outcome measures

Measure	Dexrazoxane 100mg/m2 n=4 Participants one dose of 100mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 200mg/m2 n=5 Participants one dose of 200mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 300mg/m2 n=5 Participants one dose of 300mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 400mg/m2 n=5 Participants one dose of 400mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 500mg/m2 n=5 Participants one dose of 500 mg/m2 Dexrazoxane: One dose of dexrazoxane
Participants With 95% Reduction in Topoisomerase 2 b From Baseline	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

Adverse Events

Dexrazoxane 100mg/m2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dexrazoxane 200mg/m2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Dexrazoxane 300mg/m2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dexrazoxane 400mg/m2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexrazoxane 500mg/m2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dexrazoxane 100mg/m2 n=5 participants at risk one dose of 100mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 200mg/m2 n=5 participants at risk one dose of 200mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 300mg/m2 n=5 participants at risk one dose of 300mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 400mg/m2 n=5 participants at risk one dose of 400mg/m2 dexrazoxane Dexrazoxane: One dose of dexrazoxane	Dexrazoxane 500mg/m2 n=5 participants at risk one dose of 500 mg/m2 Dexrazoxane: One dose of dexrazoxane
Skin and subcutaneous tissue disorders bruising	40.0% 2/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.
Skin and subcutaneous tissue disorders pain	20.0% 1/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	20.0% 1/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.
Blood and lymphatic system disorders anemia	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	20.0% 1/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	40.0% 2/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	20.0% 1/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.
General disorders other	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	0.00% 0/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.	20.0% 1/5 • The adverse event data were collected on the date of one dose dexrazoxane infusion, one day and two days after infusion, and one week after infusion. Some of the participants required a visit two weeks after one dose dexrazoxane infusion. Adverse event data were collected during the visit.

Additional Information

Hui-Ming Chang, MD, MPH

University of Arkansas for Medical Sciences

Phone: 501-686-7575

Email: hchang@uams.edu

Results disclosure agreements

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