Advanced Malignant Tumor
Conditions
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.
Detailed description
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. About 120 patients will be recruited in this study. Patients with solid tumors will receive Mitoxantrone Hydrochloride Liposome 20 mg/m\^2 by an intravenous infusion (IV) every 3 weeks (q3w, 1 cycle). Patients with lymphoma will receive Mitoxantrone Hydrochloride Liposome 20 mg/m\^2 by an intravenous infusion (IV) every 4 weeks (q4w, 1 cycle). All the patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator's or patient's decision.
Interventions
DRUGMitoxantrone Hydrochloride Liposome
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).
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac adverse event | up to approximately 5 years. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
China
Outcome results
None listed