A Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients

NCT06092606 | Unknown Phase 2

• 1 other identifier: CTR20232122
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose：1. Preliminary evaluation of the preventive effect of DH001 on doxorubicin-induced cardiotoxicity in cancer patients 2.To explore appropriate dosages to provide basis for dosages in subsequent confirmatory studies 3.To evaluate the effect of DH001 on the efficacy of doxorubicin treatment in cancer patients 4.To evaluate the safety of DH001 in cancer patients treated with doxorubicin

Conditions

Cancer; Heart Failure; Arrhythmia; Doxorubicin Induced Cardiomyopathy; Doxorubicin Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• The incidence of cardiac events

  The incidence of cardiac events in subjects during doxorubicin treatment

  18-24 weeks

Study Arms (3)

Control group:DH001 placebo

PLACEBO COMPARATOR

Medication: Once per day on an empty stomach in the morning. Treatment cycle: 3 days before the first administration of doxorubicin to the entire treatment cycle of doxorubicin. Dosage: DH001 placebo (8 tablets)

Drug: Control group:DH001 placebo

Trial group: DH001 low-dose group

EXPERIMENTAL

Medication: once per day on an empty stomach in the morning. Treatment cycle: 3 days before the first administration of doxorubicin to the entire treatment cycle of doxorubicin. Dosage: DH001 200mg (4 tablets) + DH001 placebo (4 tablets)

Drug: Trial group: DH001 low-dose group

Trial group: DH001 high-dose group

EXPERIMENTAL

Medication: Once per day on an empty stomach in the morning. Treatment cycle: 3 days before the first administration of doxorubicin to the entire treatment cycle of doxorubicin. Dosage: DH001 400mg (8 tablets).

Drug: Trial group: DH001 high-dose group

Interventions

Control group:DH001 placebo DRUG

Dosage: DH001 placebo (8 tablets)

Also known as: Control group

Control group:DH001 placebo

Trial group: DH001 low-dose group DRUG

Dosage: DH001 200mg (4 tablets) + DH001 placebo (4 tablets)

Trial group: DH001 low-dose group

Trial group: DH001 high-dose group DRUG

Dosage: DH001 400mg (8 tablets).

Trial group: DH001 high-dose group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Subjects who meet all the following criteria can be included in this study：
• \. Newly diagnosed lymphoma or non-lymphoma patients (breast cancer, soft tissue sarcoma, etc.) as well as lymphoma or non-lymphoma patients that do not have a history of anthracycline treatment (doxorubicin, epirubicin, pyrandoxorubicin, daunorubicin, demethoxydaunorubicin, aclarithromycin, mitoxantrone, etc.)；Cancer patients should meet the following requirements:
• Lymphoma：
• Lymphoma patients confirmed by histopathology；
• No previous history of anthracyclines treatment；
• Doxorubicin treatment planned for no less than 6 cycles；
• Non-lymphoma (breast cancer, soft tissue sarcoma, etc.)：
• Subjects with malignant tumors (breast cancer, soft tissue sarcoma, etc.) confirmed by histopathology and/or cytology；
• Subjects planned to be treated with doxorubicin continuously for no less than 4 cycles（The cumulative dose of doxorubicin is no less than 240 mg/m2.）；
• Subjects with no history of systemic chemotherapy involving anthracyclines； 2.Age 18-75 years old, male or female； 3.ECOG PS score 0-1； 4.Expected survival ≥24 weeks； 5. Vital organs function well, that is, relevant examination indicators within 14 days before randomization meet the following requirements：
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• Blood routine tests：
• Hemoglobin ≥95 g/L (no blood transfusion within 14 days)；
• Neutrophil count ≥1.5×109/L；
• Platelet count ≥75×109/L；

You may not qualify if:

• \- 1.Subjects scheduled to receive other anthracycline regimens； 2.Subjects who have previously received or plan to receive radiotherapy with a target area including the heart or left axillary lymph node； 3.HER-2 positive breast cancer patients； 4.Subjects with existing cardiac clinical symptoms or diseases that are not well controlled, such as：
• Cardiac Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) \<55%；
• QTc \> 450ms (men); QTc \> 470ms (women) (QTc interval calculated using the Fridericia Formula; if QTc is abnormal, it can be detected three times continuously with an interval of 2 minutes, and the average value is then taken)；
• Serum biomarkers：
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• Cardiac troponin T (cTnT, if applicable): cTnT \> upper limit of normal ；
• cardiac troponin I（cTnI）：cTnI\>upper limit of normal；
• N-terminal pro-BNP：NT-proBNP≥upper limit of normal；
• B-type natriuretic peptide（BNP，if applicable）：BNP≥upper limit of normal； 4）New York Heart Association Classification (NYHA standards) of cardiac function \>Class II； 5） Unstable angina； 6） Heart failure； 7） Moderate valvular heart disease or above; 8） Myocardial infarction within 1 year before enrollment； 9）Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention； 5.Subjects with high blood pressure that is not well controlled using antihypertensive medication (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) (based on the average of BP readings obtained from ≥2 measurements)，the above parameters are allowed to be achieved through the use of antihypertensive therapy；Subjects with a history of hypertensive crisis or hypertensive encephalopathy； 6.Subjects with type 1 diabetes（T1D）; 7.Subjects with a body mass index ≥28 kg/m2； 8.Subjects with a history of previous heart transplant or complex congenital heart disease.
• Subjects that have undergone major surgical treatment (except for diagnosis) within 4 weeks before enrollment or are expected to require major surgical treatment during the study period (except for tumor resection surgery)； 10.Subjects with congenital or acquired immunodeficiency diseases, including human immunodeficiency virus (HIV), or history of organ transplantation or allogeneic stem cell transplantation； 11.Subjects with known active infections or active pulmonary tuberculosis infections shall not be included in the study；However, patients infected with hepatitis B virus (HBV) and hepatitis C virus (HCV) whose condition is stable after antiviral treatment can be enrolled.
• Subjects with a history of other malignancies within 5 years, excluding adequately treated cervical cancer in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ.
• Subjects whom the investigators believe have lesions that require emergency palliative radiotherapy/emergency surgery (such as spinal cord compression, cerebral herniation, pathological fracture).
• Subjects possess physical examination or clinical experimental findings that, investigators believe, may interfere with the results or increase the subject's risk of treatment complications；subjects who suffer from other uncontrollable diseases.
• Subjects who are unable to swallow pills, subjects with malabsorption syndrome, or any condition that affects gastrointestinal absorption.
• Subjects with obvious mental disorders or epilepsy; subjects with no behavioral or cognitive abilities; drug addicts; pregnant or lactating women.

Sponsors & Collaborators

• Monyan Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Harbin Institute of Hematology and Cancer

Harbin, Heilongjiang, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Heart Failure; Arrhythmias, Cardiac

Interventions

Control Groups; Population Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Demography; Population Characteristics

Study Officials

• Jun Zhu

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Hongmei Jing

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Hui Zhou

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Yufu Li

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Hesheng He

  The First Affilaited Hospital of Wannan Medical College

  PRINCIPAL INVESTIGATOR

• Zeping Zhou

  The Second Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

• Wenbin Qian

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Xiaojia Wang

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Jiwei Liu

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

• Zhenchang Sun

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Ma

CONTACT

+86 133 0451 8000; majun0322@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 23, 2023
• Study Start: April 4, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CN (1)