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

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05089461
Collaborator
(none)
120
Enrollment
1
Arm
23
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Mitoxantrone Hydrochloride Liposome
Phase 2

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/m2 by an intravenous infusion (IV) every 3 weeks (q3w, 1 cycle). Patients with lymphoma will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Oct 30, 2021
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Mitoxantrone Hydrochloride Liposome Injection

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
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).

Outcome Measures

Primary Outcome Measures

  1. Cardiac adverse event [up to approximately 5 years.]

Secondary Outcome Measures

  1. Overall response rate (ORR) [up to approximately 3 years]

  2. Progression-free survival (PFS) [up to approximately 3 years.]

  3. Overall survival (OS) [up to approximately 5 years]

  4. Incidence of treatment emergent adverse event (TEAE) [up to approximately 3 years.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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/m2 < doxorubicin ≤550 mg/m2;

  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);

  1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05089461
Other Study ID Numbers:
  • HE071-CSP-020
First Posted:
Oct 22, 2021
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2021