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A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer

Safety, Tolerability, and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer: A Multicenter, Open-label, Phase Ⅱ Study

NCT05100329•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mitoxantrone hydrochloride liposome injection in patients with advanced pancreatic cancer.

Detailed Description

This is a multicenter, open-label, phase Ⅱ study aimed to evaluate the safety, tolerability, and efficacy of mitoxantrone hydrochloride liposome injection in patients with advanced pancreatic cancer. Patients enrolled in this study will receive mitoxantrone hydrochloride liposome injection every 3 weeks (q3w, a cycle) until disease progression, intolerable toxicity, death, or withdrawal by investigator or patient decision (a maximum of 8 cycles).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients fully understand and voluntarily participate in this study and sign informed consent;
•2. Aged 18-75 years (inclusive), without gender limitation;
•3. Histologically or cytologically confirmed advanced pancreatic tumors;
•4. Patients with locally progressive or metastatic pancreatic cancer who have disease progression after receiving first line or above standard treatment.
•5. At least one measurable lesion according to RECIST v1.1 at baseline;
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
•7. Adequate organ function defined as (No G-CSF treatment or blood transfusion within 2 weeks prior to the first dose):
•* Absolute neutrophil count (ANC) ≥1.5\*10\^9/L;
•* Hemoglobin ≥ 90 g/L;
•* Platelet count ≥ 100 \* 10\^9/L;
+6 more criteria

Exclusion Criteria

•1. History of severe allergy to mitoxantrone hydrochloride or any excipients of the study drug;
•2. History of other malignant tumor in previous 3 years, not including cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma.
•3. Cerebral or meningeal metastases;
•4. Patients with chronic hepatitis B (HBsAg positive with HBV DNA ≥ 2000 IU/mL), chronic hepatitis C (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 \< 3 months;
•6. Previous treatment with adriamycin or other anthracyclines, with the total cumulative dose (doxorubicin equivalent) \>350 mg/m\^2;
•7. AEs from the previous treatment have not resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as alopecia, hyperpigmentation);
•8. Patients with the following cardiac function defects:
•* Long QTc syndrome or QTc interval \> 480 ms;
•* Complete left bundle branch block, II-III degree atrioventricular block;
+16 more criteria

Key Dates

Start Date

November 1, 2021

Primary Completion Date

November 1, 2023

Completion Date

May 1, 2024

Last Updated

October 29, 2021

Enrollment

ESTIMATED participants

Conditions

Advanced Pancreatic Cancer

Interventions

Mitoxantrone Hydrochloride Liposome injection

DRUG

Contacts

Xuefang Xia

CONTACT

+86-010-63932012 xiaxuefang@mail.ecspc.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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