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

NCT03930680 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 262180R01HL151993
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.

Conditions

Degradation of Top2b and Top2a in Human by Dexrazoxane; Time Course and Degradation of Top2b in Human by Dexrazoxane; Effects of Dexrazoxane on Healthy Human

Keywords

Dexrazoxane; Topoisomerase 2b; Human; Doxorubicin cardio-toxicity; Cardio-oncology; Onco-cardiology; Prevention of cardio-toxicity by doxorubicin; Early administration of dexrazoxane

Outcome Measures

Primary Outcomes (1)

• Participants With 95% Reduction in Topoisomerase 2 b From Baseline

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

  8 hours after dexrazoxane administration

Study Arms (5)

Dexrazoxane 100mg/m2

EXPERIMENTAL

one dose of 100mg/m2 dexrazoxane

Drug: Dexrazoxane

Dexrazoxane 200mg/m2

EXPERIMENTAL

one dose of 200mg/m2 dexrazoxane

Drug: Dexrazoxane

Dexrazoxane 300mg/m2

EXPERIMENTAL

one dose of 300mg/m2 dexrazoxane

Drug: Dexrazoxane

Dexrazoxane 400mg/m2

EXPERIMENTAL

one dose of 400mg/m2 dexrazoxane

Drug: Dexrazoxane

Dexrazoxane 500mg/m2

EXPERIMENTAL

one dose of 500 mg/m2

Drug: Dexrazoxane

Interventions

Dexrazoxane DRUG

One dose of dexrazoxane

Also known as: Zinecard

Dexrazoxane 100mg/m2; Dexrazoxane 200mg/m2; Dexrazoxane 300mg/m2; Dexrazoxane 400mg/m2; Dexrazoxane 500mg/m2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women,
• Age 18-65,
• Not pregnant, Not currently breast feeding
• No current illness,

You may not qualify if:

• Pregnancy, currently breast feeding
• Current illness,
• History of cardiac, or renal disease

Sponsors & Collaborators

• University of Arkansas: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (27)

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• Chang HM, Hsu JY, Ahn C, Yeh ETH. Prevention of Heart Failure Induced by Doxorubicin with Early Administration of Dexrazoxane (PHOENIX Study): dose response and time course of dexrazoxane-induced degradation of topoisomerase 2b. Cardiooncology. 2025 May 2;11(1):42. doi: 10.1186/s40959-025-00339-0.

  PMID: 40317097 RESULT

MeSH Terms

Interventions

Dexrazoxane

Intervention Hierarchy (Ancestors)

Razoxane; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

In animal studies, Top2b expression can be directly measured in heart tissues; however, this is not feasible in human participants. Therefore, peripheral blood mononuclear cells were chosen as a surrogate tissue to assess Top2b degradation. Our study participants were adult women, so the dose-response curve and time course may not be applicable to the pediatric cancer population. Our study evaluates the dose-response and time course of dexrazoxane's effects on Top2a and Top2b expression.

Results Point of Contact

• Title: Hui-Ming Chang, MD, MPH
• Organization: University of Arkansas for Medical Sciences

hchang@uams.edu

501-686-7575

Study Officials

• Hui-Ming Chang, MD,MPH

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will receive one dose of dexrazoxane.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: September 14, 2021
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2025
• Last Updated: July 8, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)