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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930680
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Hui-Ming Chang, University of Missouri-Columbia

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
Healthy Drug: Dexrazoxane Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 100mg/m2
one dose of 100mg/m2 dexrazoxane
Drug: Dexrazoxane
One lower than FDA approved dose of dexrazoxane
Other Name: Zinecard

Experimental: 200mg/m2
one dose of 200mg/m2 dexrazoxane
Drug: Dexrazoxane
One lower than FDA approved dose of dexrazoxane
Other Name: Zinecard

Experimental: 300 mg/m2
one dose of 300mg/m2 dexrazoxane
Drug: Dexrazoxane
One lower than FDA approved dose of dexrazoxane
Other Name: Zinecard

Experimental: 400 mg/m2
one dose of 400mg/m2 dexrazoxane
Drug: Dexrazoxane
One lower than FDA approved dose of dexrazoxane
Other Name: Zinecard

Experimental: 50mg/m2 or 500 mg/m2
one dose of either 50 mg/m2 or 500 mg/m2 dexrazoxane
Drug: Dexrazoxane
One lower than FDA approved dose of dexrazoxane
Other Name: Zinecard




Primary Outcome Measures :
  1. Degradation of Topoisomerase 2 b [ Time Frame: 32 hours after administration ]
    Topoisomerase 2 b degradation to less than 1% of baseline level in human blood of 5 volunteers.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women,
  • Age 18-65,
  • Not pregnant, Not currently breast feeding
  • No current illness,
  • Not on prescribed medication,or nutritional supplement

Exclusion Criteria:

  • Pregnancy, currently breast feeding
  • Current illness,
  • On prescribed medication or nutritional supplement
  • History of cardiac, or renal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930680


Contacts
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Contact: Hui-Ming Chang, MD,MPH 573-882-8280 changhu@health.missouri.edu
Contact: Edward TH Yeh, MD 573-882-8280

Sponsors and Collaborators
Hui-Ming Chang
Investigators
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Principal Investigator: Hui-Ming Chang, MD,MPH University of Missouri-Columbia
Publications:

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Responsible Party: Hui-Ming Chang, Co-Director, Center for Precision Medicine, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03930680    
Other Study ID Numbers: 2014006
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Dexrazoxane
Razoxane
Antineoplastic Agents
Cardiotonic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimitotic Agents
Mitosis Modulators