Clinical trial · Interventional
A Study to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor
An Open-label, Multi-center Phase II Clinical Trial to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor
NCT05089461CI-TRIAL-00060797suspendedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): sponsor decided to stop
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Tumor | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitoxantrone Hydrochloride Liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mitoxantrone Hydrochloride Liposome Injection
- description
- 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.
- interventionNames
- Drug: Mitoxantrone Hydrochloride Liposome
Primary outcomes (1)
- measure
- Cardiac adverse event
- timeFrame
- up to approximately 5 years.
Secondary outcomes (4)
- measure
- Overall response rate (ORR)
- timeFrame
- up to approximately 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients fully understand and voluntarily participate in this study and sign informed consent; 2. Age ≥18 years; 3. Histologically confirmed diagnosis of late-stage solid tumor or peripheral T cell lymphoma (PTCL); 4. Has received standard first-line treatment; 5. 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; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; 7. 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); 8. 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. Exclusion Criteria: 1. History of allergy to mitoxantrone hydrochloride or liposomal drugs; 2. 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; 3. Cerebral or meningeal metastases; 4. 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; 5. Life expectancy ≤ 12 weeks; 6. 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); 7. Cardiac dysfunction, including: 1)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.
References
Publications (0)
Data not yet available
No reference posted for this study.