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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
Women
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 a woman.
Select...
I am between 18 and 65 years old.

PHOENIX1 Trial Timeline

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
94%
Anemia
79%
Fatigue
77%
Lymphocytes decreased
69%
Neutrophil count decreased
53%
Hypoalbuminemia
50%
Constipation
47%
White blood cell decreased
44%
Edema limbs
42%
Hypocalcemia
39%
Nausea
39%
Hyponatremia
35%
Platelet count decreased
35%
INR increased
34%
Alopecia
32%
Mucositis oral
31%
Hypokalemia
31%
Febrile neutropenia
29%
Headache
29%
Fever
27%
Diarrhea
26%
Alkaline phosphatase increased
24%
Vomiting
24%
Anorexia
23%
Hematuria
23%
Thromboembolic event
23%
Hyperglycemia
21%
Aspartate aminotransferase increased
21%
Cough
21%
Activated partial thromboplastin time prolonged
19%
Dyspnea
19%
Alanine aminotransferase increased
18%
Arthralgia
18%
Hypernatremia
16%
Urinary tract infection
16%
Abdominal pain
15%
Productive cough
15%
Proteinuria
15%
Hypoglycemia
13%
Infusion-related reaction
13%
Bone pain
13%
Hypertension
11%
Anxiety
11%
Ejection fraction decreased
11%
Back pain
11%
Muscle pain
10%
Peripheral sensory neuropathy
10%
Tumor pain
10%
Chills
10%
Creatinine increased
10%
Myalgia
10%
Dysgeusia
10%
Insomnia
8%
Nasal congestion
8%
Upper respiratory infection
8%
Hypotension
8%
Hiccups
8%
Rash maculo-papular
8%
Lung infection
8%
Pain in extremity
8%
Post nasal drip
6%
Blood bilirubin increased
6%
Flu like symptoms
6%
Gastric hemorrhage
6%
Hyperkalemia
6%
Sepsis
6%
Cholesterol high
6%
Gastroesophageal reflux disease
6%
Spinal fracture
6%
Nail ridging
6%
Blurred vision
6%
Hypomagnesemia
6%
Dizziness
6%
Spasticity
6%
Nail discoloration
6%
Malaise
5%
Sinusitis
5%
Lymphedema
5%
Epistaxis
5%
Dysphasia
5%
Rash acneiform
5%
Confusion
5%
Sore throat
5%
Non-cardiac chest pain
5%
Watering eyes
5%
Dyspepsia
5%
Oral pain
5%
Fracture
5%
Syncope
5%
Papulopastular rash
3%
GGT increased
3%
Hypercalcemia
3%
Muscle spasms
3%
Hemorrhoids
3%
Nail infection
3%
Dysphagia
3%
Dry skin
3%
Hypertriglyceridemia
3%
Flank pain
3%
Phantom pain
3%
Ascites
3%
Failure to thrive
3%
Dysarthria
3%
Depression
3%
Skin infection
3%
Nail loss
3%
Urticaria
3%
Pneumonitis
3%
Hand and foot syndrome
3%
Dehydration
3%
Urinary frequency
3%
Abdominal distension
3%
Lower gastrointestinal hemorrhage
3%
Colitis
3%
Edema trunk
3%
Photosensitivity
3%
Hoarseness
3%
Hypothyroidism
3%
Knee pain
3%
Dry mouth
2%
Hyperparathyroidism
2%
Restlessness
2%
Bloating
2%
Ear pain
2%
Ear sensitivity
2%
Anal hemorrhage
2%
Flatulence
2%
Wound infection
2%
Allergic rhinitis
2%
Bacteremia
2%
Upper gastrointestinal hemorrhage
2%
Neuroma
2%
Capillary leak syndrome
2%
Myositis
2%
Thigh pain
2%
Tremor
2%
Skin hyperpigmentation
2%
Lip swelling
2%
Sinus tachycardia
2%
Mental status altered
2%
Vaginal discharge
2%
Rash non pruritic
2%
Vaginal infection
2%
Arthritis
2%
Akathisia
2%
Lymph node pain
2%
Mucosal infection
2%
Tooth infection
2%
Shoulder pain
2%
Pneumonia
2%
Palmar plantar erythrodysesthesia syndrome
2%
Subcutaneous tissue disorder
2%
Bleeding hemorrhoids
2%
Hypermagnesemia
2%
Hyperthyroidism
2%
Muscle aches
2%
Glaucoma
2%
Respiratory failure
2%
Leukocytosis
2%
Sinus bradycardia
2%
Gum bleeding
2%
Pain
2%
Eye infection
2%
Hallucinations
2%
Wheezing
2%
Intercardial thrombic
2%
Suicide
2%
Irritability
2%
Rectal bleeding
2%
Esophagitis
2%
Thrombocytopenia
2%
Myocardial infarction
2%
Sudden death NOS
2%
Chest pain - cardiac
2%
Localized edema
2%
Rectal ulcer
2%
Small intestinal obstruction
2%
Stomach pain
2%
Rash pustular
2%
Rhinitis infection
2%
Chest wall pain
2%
Vertigo
2%
Penile pain
2%
Sweating
2%
Tick bites
2%
Palpitations
2%
Tinnitus
2%
Allergic reaction
2%
Bruising
2%
Extrapyramidal disorder
2%
Sinus pain
2%
Elevated PSA
2%
Superficial thrombophlebitis
2%
Pelvic pain
2%
Psychosis
2%
Nodule left forearm
2%
Hot flashes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1: Doxorubicin and Upfront Dexrazoxane
Arm 2: Control (Doxorubicin and Standard of Care 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

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
485 Previous Clinical Trials
149,848 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 100mg/m2, Dexrazoxane 200mg/m2, Dexrazoxane 300mg/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

Who else is applying?

What state do they live in?
Kansas
What site did they apply to?
University of Arkansas for Medical Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I would like to help with the study.
PatientReceived 1 prior treatment
Recent research and studies
~5 spots leftby Oct 2024