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

Sponsor
University of Arkansas (Other)
Overall Status
Recruiting
CT.gov ID
NCT03930680
Collaborator
(none)
25
Enrollment
1
Location
5
Arms
36
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Each subject will receive one dose of dexrazoxane.Each subject will receive one dose of dexrazoxane.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexrazoxane 100mg/m2

one dose of 100mg/m2 dexrazoxane

Drug: Dexrazoxane
One dose of dexrazoxane
Other Names:
  • Zinecard

    		•
    Experimental: Dexrazoxane 200mg/m2

    one dose of 200mg/m2 dexrazoxane

    Drug: Dexrazoxane
    One dose of dexrazoxane
    Other Names:
  • Zinecard

    		•
    Experimental: Dexrazoxane 300mg/m2

    one dose of 300mg/m2 dexrazoxane

    Drug: Dexrazoxane
    One dose of dexrazoxane
    Other Names:
  • Zinecard

    		•
    Experimental: Dexrazoxane 400mg/m2

    one dose of 400mg/m2 dexrazoxane

    Drug: Dexrazoxane
    One dose of dexrazoxane
    Other Names:
  • Zinecard

    		•
    Experimental: Dexrazoxane 500mg/m2

    one dose of 500 mg/m2

    Drug: Dexrazoxane
    One dose of dexrazoxane
    Other Names:
  • Zinecard

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Degradation of Topoisomerase 2 b [48 hours after administration]

      Topoisomerase 2 b degradation to less than 15 percent of baseline level in human blood of 5 volunteers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205

    Sponsors and Collaborators

    • University of Arkansas

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT03930680
    Other Study ID Numbers:
    • 262180
    First Posted:
    Apr 29, 2019
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Heart Failure
    Dexrazoxane
    Razoxane

    Study Results

    No Results Posted as of Mar 31, 2022