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Anti-tumor antibiotic

Dexrazoxane for Preventing Heart Failure (PHOENIX1 Trial)

Phase 1

Recruiting

Led By Hui-Ming Chang, MD,MPH

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No current illness

Age 18-65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after administration

Awards & highlights

PHOENIX1 Trial Summary

This trial will test whether Dexrazoxane can prevent Doxorubicin-related heart damage.

Who is the study for?

This trial is for healthy women aged 18-65 who are not pregnant, not breastfeeding, and have no current illnesses. It's not open to those with a history of kidney or heart disease, or who are currently ill.Check my eligibility

What is being tested?

The study is testing if Dexrazoxane given early can prevent heart damage caused by Doxorubicin, a drug used in cancer treatment. The focus is on preventing heart failure in patients receiving Doxorubicin.See study design

What are the potential side effects?

Dexrazoxane may cause side effects such as nausea, vomiting, diarrhea, dizziness and low blood cell counts which could increase infection risk.

PHOENIX1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have any current illnesses.

Select...

I am between 18 and 65 years old.

PHOENIX1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Degradation of Topoisomerase 2 b

Side effects data

From 2022 Phase 2 trial • 73 Patients • NCT02584309

100%

Anemia

100%

Alopecia

90%

Lymphocytes decreased

80%

Nausea

70%

Fatigue

70%

Hypocalcemia

60%

Hypokalemia

60%

Constipation

50%

Alkaline phosphatase increased

50%

Creatinine increased

50%

Anxiety

40%

White blood cell decreased

40%

Headache

30%

Febrile neutropenia

30%

Diarrhea

30%

Mucositis oral

30%

Hypernatremia

30%

Neutrophil count decreased

30%

Platelet count decreased

30%

Bone pain

30%

Hyponatremia

20%

Pain in extremity

20%

Fever

20%

Hyperglycemia

20%

Hypertriglyceridemia

20%

Back pain

20%

Peripheral sensory neuropathy

20%

Hypoalbuminemia

20%

Flushing

20%

Thromboembolic event

10%

Pruritus

10%

Respiratory failure

10%

Abdominal pain

10%

Flu like symptoms

10%

Sinus tachycardia

10%

Sinus bradycardia

10%

Alanine aminotransferase increased

10%

Stomach pain

10%

Oral dysethesia

10%

Vomiting

10%

Edema limbs

10%

Rash acneiform

10%

Wound complication

10%

Lung infection

10%

Anorexia

10%

Pharyngitis

10%

Rash pustular

10%

Fracture

10%

Spasticity

10%

INR increased

10%

Hypercalcemia

10%

Hypermagnesemia

10%

Chest wall pain

10%

Sinus pain

10%

Myositis

10%

Myalgia

10%

Dyspnea

10%

Hoarseness

10%

Hematuria

10%

Proteinuria

10%

Nasal congestion

10%

Depression

10%

Pneumothorax

10%

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)

Arm 1: Doxorubicin and Upfront Dexrazoxane

PHOENIX1 Trial Design

5Treatment groups

Experimental Treatment

Group I: Dexrazoxane 500mg/m2Experimental Treatment1 Intervention

one dose of 500 mg/m2

Group II: Dexrazoxane 400mg/m2Experimental Treatment1 Intervention

one dose of 400mg/m2 dexrazoxane

Group III: Dexrazoxane 300mg/m2Experimental Treatment1 Intervention

one dose of 300mg/m2 dexrazoxane

Group IV: Dexrazoxane 200mg/m2Experimental Treatment1 Intervention

one dose of 200mg/m2 dexrazoxane

Group V: Dexrazoxane 100mg/m2Experimental Treatment1 Intervention

one dose of 100mg/m2 dexrazoxane

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexrazoxane

2016

Completed Phase 2

~80

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

150,258 Total Patients Enrolled

Hui-Ming Chang, MD,MPHPrincipal InvestigatorUniversity of Arkansas

Media Library

Dexrazoxane (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03930680 — Phase 1

Healthy Subjects Research Study Groups: Dexrazoxane 300mg/m2, Dexrazoxane 100mg/m2, Dexrazoxane 200mg/m2, Dexrazoxane 500mg/m2, Dexrazoxane 400mg/m2

Healthy Subjects Clinical Trial 2023: Dexrazoxane Highlights & Side Effects. Trial Name: NCT03930680 — Phase 1

Dexrazoxane (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03930680 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for involvement in this research project?

"Affirmative. As per the data on clinicaltrials.gov, this medical experiment which was initially posted on June 1st 2021 is actively accepting participants. A total of 25 volunteers need to be recruited from one clinic site."

Answered by AI

Does this experimental research accept participants over the age of thirty?

"As outlined in the eligibilty criteria, this trial is open to patients aged between 18 and 65."

Answered by AI

Has Dexrazoxane been employed in any other scientific experiments?

"Currently, 14 clinical trials are testing Dexrazoxane's potential efficacy and safety. Of those studies, 6 have progressed to the final phase of research. Sioux Falls is hosting most of these experiments; however, 1074 other medical centres throughout America are also running similar investigations for this drug."

Answered by AI

To whom is this clinical research open?

"This clinical trial seeks 25 individuals with heart failure aged from 18 to 65 years old. Applicants must meet the following criteria: no concurrent illness, female sex, age range of 18-65, not pregnant and lactating."

Answered by AI

To what extent has the participant cap been reached for this research endeavor?

"Affirmative. Clinicaltrials.gov's information clearly states that this experiment is presently in need of participants, initially posted on June 1st 2021 and recently updated on March 15th 2022. 25 subjects are required to be enrolled at a single medical centre."

Answered by AI

To what extent might Dexrazoxane pose a risk to those undergoing treatment?

"Due to the limited amount of data available concerning its efficacy and safety, dexrazoxane has been evaluated as a 1 on our risk assessment scale."

Answered by AI

To which conditions does Dexrazoxane typically lend therapeutic support?

"Dexrazoxane is typically used to manage doxorubicin toxicity; however, it can be useful for treating anthracycline-induced chemotherapy side effects, malignant neoplasms, and drug extravasation."

Answered by AI