Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane (PHOENIX1)

February 15, 2024 updated by: University of Arkansas

Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a study on volunteers to determine effective dose of dexrazoxane in degrading Topoisomerase 2 b in human blood samples. Each participant will receive one dose of dexrazoxane. Blood samples will be collected to determine the time course and degradation of Topoisomerase 2b and Topoisomerase 2a

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hui-Ming Chang, MD,MPH
  • Phone Number: 501-686-7575
  • Email: hchang@uams.edu

Study Contact Backup

  • Name: Edward TH Yeh, MD
  • Phone Number: 501-686-7045
  • Email: eyeh@uams.edu

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
          • Hui-Ming Chang, MD, MPH
          • Phone Number: 501-686-7575
          • Email: hchang@uams.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexrazoxane 100mg/m2
one dose of 100mg/m2 dexrazoxane
One dose of dexrazoxane
Other Names:
  • Zinecard
Experimental: Dexrazoxane 200mg/m2
one dose of 200mg/m2 dexrazoxane
One dose of dexrazoxane
Other Names:
  • Zinecard
Experimental: Dexrazoxane 300mg/m2
one dose of 300mg/m2 dexrazoxane
One dose of dexrazoxane
Other Names:
  • Zinecard
Experimental: Dexrazoxane 400mg/m2
one dose of 400mg/m2 dexrazoxane
One dose of dexrazoxane
Other Names:
  • Zinecard
Experimental: Dexrazoxane 500mg/m2
one dose of 500 mg/m2
One dose of dexrazoxane
Other Names:
  • Zinecard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degradation of Topoisomerase 2 b
Time Frame: 48 hours after administration
Topoisomerase 2 b degradation to less than 15 percent of baseline level in human blood of 5 volunteers.
48 hours after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hui-Ming Chang, MD,MPH, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2021

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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