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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• \- 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;

• 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;

• 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.

∙ 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.

Locations
Other Locations
China
Harbin Institute of Hematology and Cancer
RECRUITING
Harbin
Contact Information
Primary
Jun Ma
majun0322@126.com
+86 133 0451 8000
Time Frame
Start Date: 2023-04-04
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 90
Treatments
Placebo_comparator: Control group:DH001 placebo
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)
Experimental: Trial group: DH001 low-dose group
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)
Experimental: Trial group: DH001 high-dose group
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).
Sponsors
Leads: Monyan Pharmaceutical (Shanghai) Co., Ltd.

This content was sourced from clinicaltrials.gov