A Study to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor

NCT05089461 | Suspended Phase 2

• 1 other identifier: HE071-CSP-020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label, phase II study to evaluate the cardiac safety of Mitoxantrone Hydrochloride Liposome in patients with advanced malignant tumor who has received at least first-line treatment.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (1)

• Cardiac adverse event

  up to approximately 5 years.

Secondary Outcomes (4)

• Overall response rate (ORR)

  up to approximately 3 years

• Progression-free survival (PFS)

  up to approximately 3 years.

• Overall survival (OS)

  up to approximately 5 years

• Incidence of treatment emergent adverse event (TEAE)

  up to approximately 3 years.

Study Arms (1)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

Patients with advanced malignant tumor will receive 20 mg/m\^2 Mitoxantrone Hydrochloride Liposome by an intravenous infusion (IV) on day 1 of each treatment cycle.

Drug: Mitoxantrone Hydrochloride Liposome

Interventions

Mitoxantrone Hydrochloride Liposome DRUG

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV), 20 mg/m\^2. Solid tumors: every 3 weeks (q3w, 1 cycle), Lymphoma: every 4 weeks (q4w, 1 cycle).

Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

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

You may qualify if:

• Patients fully understand and voluntarily participate in this study and sign informed consent;
• Age ≥18 years;
• Histologically confirmed diagnosis of late-stage solid tumor or peripheral T cell lymphoma (PTCL);
• Has received standard first-line treatment;
• Previous treated with anthracyclines, and converted to doxorubicin at equivalent doses. The cumulative dose of doxorubicin is 160 mg/m\^2 \< doxorubicin ≤550 mg/m\^2;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
• Adequate organ function:
• Absolute neutrophil count (ANC) \>1.5 10\^9/L;
• Hemoglobin \> 90 g/L;
• Platelet count \> 75 10\^9/L;
• Creatinine \< 1.5 upper limit of normal (ULN);
• Total bilirubin \< 1.5 ULN (\< 3 ULN in patients with hepatic metastasis);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 ULN (\< 5 ULN in patients with hepatic metastasis);
• Patients of childbearing potential must agree to use effective contraceptive measures from screening until 6 months after the end of the last dose; Female patients must have a negative pregnancy test before enrolment.

You may not qualify if:

• History of allergy to mitoxantrone hydrochloride or liposomal drugs;
• Other malignant tumors in the past 3 years, excluding cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have been radically treated;
• Cerebral or meningeal metastases;
• HBsAg or HBcAb positive with HBV DNA ≥ 2000 IU/mL, HCV antibody positive with HCV RNA above the lower limit of detection of the study center, or human immunodeficiency virus (HIV) antibody positive;
• Life expectancy ≤ 12 weeks;
• AEs from the previous treatment \> Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as alopecia, hyperpigmentation);
• Cardiac dysfunction, including:
• )Long QT interval syndrome; 2)High-degree atrioventricular block; 3)Malignant arrhythmia poorly controlled by medication; 4)A history of chronic heart failure with NYHA≥3; 5)Severe heart valve regurgitation or stenosis requiring treatment; 6)Acute coronary syndrome, severe pericardial disease, severe myocardial disease within 6 months prior to screening; 7)Poorly controlled hypertension (defined as systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than100 mmHg, measured ≥3 times, under control of antihypertensive drug); 8)Echocardiography showed LVEF \< 50%; 8.Active bacterial or fungal infection requiring systemic intravenous therapy within 1 week before the first dose; 9.Use of other anticancer treatment within 4 weeks prior to the first dose; 10.Enrolled in any other clinical trials within 4 weeks prior to the first dose; 11.Patients underwent major surgery within 3 months prior to the first dose, or have a surgical schedule during the study period;; 12.Thrombosis or thromboembolism within 6 months prior to the first dose; 13.Lactating female; 14.Serious and/or uncontrolled systemic diseases; 15.Not suitable for this study as decided by the investigator due to other reasons.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

the first affiliated hospital of Dalian medical university

Dalian, Liaoning, 116011, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: October 22, 2021
• Study Start: March 7, 2022
• Primary Completion: June 20, 2022
• Study Completion: December 30, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)