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Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03930680

Recruitment Status Not yet recruiting

First Posted April 29, 2019

Last update posted April 5, 2021

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:Healthy
  • Intervention/Treatment: Drug: Dexrazoxane
  • 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
  • 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: May 2021
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: May 2025
Arms and interventions
Arm Intervention/treatment
Experimental: Dexrazoxane 100mg/m2
one dose of 100mg/m2 dexrazoxane
Drug: Dexrazoxane
One dose of dexrazoxane
Experimental: Dexrazoxane 200mg/m2
one dose of 200mg/m2 dexrazoxane
Drug: Dexrazoxane
One dose of dexrazoxane
Experimental: Dexrazoxane 300mg/m2
one dose of 300mg/m2 dexrazoxane
Drug: Dexrazoxane
One dose of dexrazoxane
Experimental: Dexrazoxane 400mg/m2
one dose of 400mg/m2 dexrazoxane
Drug: Dexrazoxane
One dose of dexrazoxane
Experimental: Dexrazoxane 500mg/m2
one dose of 500 mg/m2
Drug: Dexrazoxane
One dose of dexrazoxane
Outcome Measures
  • Primary Outcome Measures: 1. Degradation of Topoisomerase 2 b [ Time Frame: 48 hours after administration ]
    Topoisomerase 2 b degradation to less than 5 percent of baseline level in human blood of 5 volunteers.
Eligibility Criteria
  • Ages Eligible for Study: 18 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

Contacts and Locations
Contacts

Contact: Hui-Ming Chang, MD,MPH 501-5266000 ext 25116 hchang@uams.edu

Contact: Edward TH Yeh, MD 501-686-7045 eyeh@uams.edu

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock

Sponsors and Collaborators

University of Arkansas

Investigators

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

More Information