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CancerPhase 2NCT06092606

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

A Phase 2 study testing Trial group: DH001 low-dose group and Trial group: DH001 high-dose group in people with Cancer and Heart Failure, run by Monyan Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cancer, Heart Failure, Arrhythmia
What is being tested?
Trial group: DH001 low-dose group and Trial group: DH001 high-dose group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
4 Apr 2023to 31 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who meet all the following criteria can be included in this study：
  • 1. 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；
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  • 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：
  • <!-- -->
  • Blood routine tests：
  • Hemoglobin ≥95 g/L (no blood transfusion within 14 days)；
  • Neutrophil count ≥1.5×109/L；
  • Platelet count ≥75×109/L；
  • Blood biochemical tests：
  • Total bilirubin ≤ 1.5×ULN ( upper limit of normal )；
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0×ULN；
  • Creatinine (Cr) ≤1.5×ULN or creatinine clearance rate ≥ 60 ml/min (CockcroftGault formula)； 6.Male or female patients of childbearing potential who are willing to use effective contraceptive methods during the study, as well as within 6 months after the last dose of treatment (e.g., double barrier, condoms, oral or injectable contraceptives, intrauterine devices, etc.). All female patients will be considered to be of childbearing potential unless the female patient has undergone natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation, etc.).The serum test results within 7 days prior to the enrollment of female patients must show that they are not pregnant , and they must be non-lactating.
  • 7.Subjects'participation should be voluntary，subjects have signed the informed consent form，show good compliance, and are able to actively cooperate with treatment and follow-up visits.

Who cannot join

  • 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：
  • <!-- -->
  • Cardiac troponin T (cTnT, if applicable): cTnT > upper limit of normal ；
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  • 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.
  • 9.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.
  • 12.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.
  • 13.Subjects whom the investigators believe have lesions that require emergency palliative radiotherapy/emergency surgery (such as spinal cord compression, cerebral herniation, pathological fracture).
  • 14.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.
  • 15.Subjects who are unable to swallow pills, subjects with malabsorption syndrome, or any condition that affects gastrointestinal absorption.
  • 16.Subjects with obvious mental disorders or epilepsy; subjects with no behavioral or cognitive abilities; drug addicts; pregnant or lactating women.
  • 17.Subjects who have participated in other clinical trials within 1 month before screening.
  • 18.Subjects determined unfit to participate by the investigator.

Trial locations and contacts

1 site in 1 country.

Jun Ma contact

+86 133 0451 8000

majun0322@126.com

China1 site, 1 recruiting

  • Harbin Institute of Hematology and Cancer

    Harbin, Heilongjiang

    Jun Ma, +86 133 0451 8000, majun0322@126.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients

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

Read the detailed description

After the subjects sign the informed consent form, meet the inclusion criteria and do not meet the exclusion criteria, they will receive a random number according to the order of enrollment, and will be randomly assigned to the DH001 low-dose group (200 mg), DH001 high-dose group (400 mg) and control group in a 1:1:1 manner according to the randomization plan；Stratification factor: Patient's tumor type [lymphoma and non-lymphoma (breast cancer, soft tissue sarcoma, etc.)].

Being tested
Control group:DH001 placebo, Trial group: DH001 low-dose group, Trial group: DH001 high-dose group
Medical subject headings
Neoplasms, Heart Failure, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control group:DH001 placeboDrug

    Also called Control group

    Dosage: DH001 placebo (8 tablets)

  • Trial group: DH001 low-dose groupDrug

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

  • Trial group: DH001 high-dose groupDrug

    Dosage: DH001 400mg (8 tablets).

Study groups in NCT06092606
Study groupRoleWhat they receive
Control group:DH001 placeboPlacebo comparatorMedication: 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)
Receives: Drug: Control group:DH001 placebo
Trial group: DH001 low-dose groupExperimentalMedication: 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)
Receives: Drug: Trial group: DH001 low-dose group
Trial group: DH001 high-dose groupExperimentalMedication: 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).
Receives: Drug: Trial group: DH001 high-dose group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of cardiac events

    The incidence of cardiac events in subjects during doxorubicin treatment

    Measured: 18-24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start4 Apr 2023
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06092606
Sponsor's protocol ID
CTR20232122
Status last verified
Oct 2023
First submitted
9 Oct 2023
Last updated
23 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trial group: DH001 low-dose group and Trial group: DH001 high-dose group in people with Cancer and Heart Failure, run by Monyan Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jun Ma (+86 133 0451 8000, majun0322@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of cardiac events (time frame: 18-24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06092606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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