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出境医 / 临床实验 / Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane (PHOENIX1)
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane (PHOENIX1)
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 |
|---|---|---|
| Healthy | Drug: Dexrazoxane | 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 (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 |
| Actual Study Start Date : | June 1, 2021 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | June 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Dexrazoxane 100mg/m2
one dose of 100mg/m2 dexrazoxane
|
Drug: Dexrazoxane
One dose of dexrazoxane
Other Name: Zinecard
|
|
Experimental: Dexrazoxane 200mg/m2
one dose of 200mg/m2 dexrazoxane
|
Drug: Dexrazoxane
One dose of dexrazoxane
Other Name: Zinecard
|
|
Experimental: Dexrazoxane 300mg/m2
one dose of 300mg/m2 dexrazoxane
|
Drug: Dexrazoxane
One dose of dexrazoxane
Other Name: Zinecard
|
|
Experimental: Dexrazoxane 400mg/m2
one dose of 400mg/m2 dexrazoxane
|
Drug: Dexrazoxane
One dose of dexrazoxane
Other Name: Zinecard
|
|
Experimental: Dexrazoxane 500mg/m2
one dose of 500 mg/m2
|
Drug: Dexrazoxane
One dose of dexrazoxane
Other Name: Zinecard
|
Outcome Measures
Primary Outcome Measures :
- 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 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
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 | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Hui-Ming Chang, PhD 501-526-6000 ext 25116 hchang@uams.edu | |
Sponsors and Collaborators
University of Arkansas
Investigators
| Principal Investigator: | Hui-Ming Chang, MD,MPH | University of Arkansas |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 25, 2019 | ||||||||
| First Posted Date ICMJE | April 29, 2019 | ||||||||
| Last Update Posted Date | June 2, 2021 | ||||||||
| Actual Study Start Date ICMJE | June 1, 2021 | ||||||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
|
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| Original Primary Outcome Measures ICMJE |
Degradation of Topoisomerase 2 b [ Time Frame: 32 hours after administration ] Topoisomerase 2 b degradation in human blood
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane | ||||||||
| Official Title ICMJE | Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer | ||||||||
| 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 | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE | Drug: Dexrazoxane
One dose of dexrazoxane
Other Name: Zinecard
|
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
25 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 2023 | ||||||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03930680 | ||||||||
| Other Study ID Numbers ICMJE | 262180 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Arkansas | ||||||||
| Study Sponsor ICMJE | University of Arkansas | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Arkansas | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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