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

Primary Purpose

Healthy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexrazoxane
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arkansas for Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dexrazoxane 100mg/m2

Dexrazoxane 200mg/m2

Dexrazoxane 300mg/m2

Dexrazoxane 400mg/m2

Dexrazoxane 500mg/m2

Arm Description

one dose of 100mg/m2 dexrazoxane

one dose of 200mg/m2 dexrazoxane

one dose of 300mg/m2 dexrazoxane

one dose of 400mg/m2 dexrazoxane

one dose of 500 mg/m2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 25, 2019
Last Updated
March 30, 2023
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT03930680
Brief Title
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane
Acronym
PHOENIX1
Official Title
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Each subject will receive one dose of dexrazoxane.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexrazoxane 100mg/m2
Arm Type
Experimental
Arm Description
one dose of 100mg/m2 dexrazoxane
Arm Title
Dexrazoxane 200mg/m2
Arm Type
Experimental
Arm Description
one dose of 200mg/m2 dexrazoxane
Arm Title
Dexrazoxane 300mg/m2
Arm Type
Experimental
Arm Description
one dose of 300mg/m2 dexrazoxane
Arm Title
Dexrazoxane 400mg/m2
Arm Type
Experimental
Arm Description
one dose of 400mg/m2 dexrazoxane
Arm Title
Dexrazoxane 500mg/m2
Arm Type
Experimental
Arm Description
one dose of 500 mg/m2
Intervention Type
Drug
Intervention Name(s)
Dexrazoxane
Other Intervention Name(s)
Zinecard
Intervention Description
One dose of dexrazoxane
Primary Outcome Measure Information:
Title
Degradation of Topoisomerase 2 b
Description
Topoisomerase 2 b degradation to less than 15 percent of baseline level in human blood of 5 volunteers.
Time Frame
48 hours after administration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Ming Chang, MD,MPH
Phone
501-686-7575
Email
hchang@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Edward TH Yeh, MD
Phone
501-686-7045
Email
eyeh@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Ming Chang, MD,MPH
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Ming Chang, MD, MPH
Phone
501-686-7575
Email
hchang@uams.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane

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