A Study Of Mitoxantrone Hydrochloride Liposome Injection In Patients With Advanced Pancreatic Cancer

Study Overview

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

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

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).

Advanced Pancreatic Cancer

DRUG: Mitoxantrone Hydrochloride Liposome injection

HE071-CSP-026

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-10-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-10-19
First Submitted that Met QC Criteria 2021-10-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-10-29
First Posted (ACTUAL) 2021-10-29	Results First Posted N/A	Last Verified 2021-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Mitoxantrone Hydrochloride Liposome Injection Patients will receive mitoxantrone hydrochloride liposome injection every 3 weeks (q3w, a cycle).	DRUG: Mitoxantrone Hydrochloride Liposome injection 20 mg/m^2, IV, on day 1 of every 3 weeks (q3w, a cycle)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Mitoxantrone Hydrochloride Liposome Injection

Patients will receive mitoxantrone hydrochloride liposome injection every 3 weeks (q3w, a cycle).

DRUG: Mitoxantrone Hydrochloride Liposome injection

20 mg/m^2, IV, on day 1 of every 3 weeks (q3w, a cycle)

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defined as the proportion of patients who have a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Up to approximately 3 years

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival (OS)	OS is defined as the time from the date of first dose until the date of death from any cause.	Up to approximately 3 years
Progression-free survival (PFS)	PFS is defined as the time from the date of first dose until the date of first documented progressive disease (PD) as per RECIST 1.1 or death from any cause, whichever occurs first	Up to approximately 3 years
Disease control rate (DCR)	DCR is defined as the proportion of patients who have a response of CR/PR or stable disease (SD) as per RECIST 1.1.	Up to approximately 3 years
Duration of response (DoR)	DoR is defined as the time from the first assessment of CR or PR until the date of first occurrence of progressive disease （PD） as per RECIST 1.1 or death from any cause, whichever occurs first.	Up to approximately 3 years
Treatment-emergent adverse events (TEAEs)		Up to approximately 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xuefang Xia

Phone Number: +86-010-63932012

Email: xiaxuefang@mail.ecspc.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Absolute neutrophil count (ANC) ≥1.5*10^9/L;
Hemoglobin ≥ 90 g/L;
Platelet count ≥ 100
10^9/L;
Creatinine ≤1.5
upper limit of normal (ULN);
Total bilirubin ≤2
ULN;
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 3
ULN (≤ 5
ULN in patients with hepatic metastasis);
Coagulation: prothrombin time (PT) or International Normalization Ratio (INR) ≤1.5
ULN. 8. Female patients must have a urine or blood HCG negative test before enrolment (except for menopause and hysterectomy); Patients and their partners must agree to use effective contraceptive measures during the study until 6 months after the end of the last dose. 9. Good compliance and willingness to cooperate with follow-up visits.

Long QTc syndrome or QTc interval > 480 ms;
Complete left bundle branch block, II-III degree atrioventricular block;
Severe, uncontrolled arrhythmias requiring pharmacological treatment;
History of chronic congestive heart failure, NYHA ≥ grade 3;
Cardiac ejection fraction < 50% within 6 months prior to screening;
Heart valve disease with CTCAE ≥ grade 3;
History of myocardial infarction, unstable angina, severe ventricular arrhythmias, severe pericardial disease, or ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to screening; 9. Uncontrollable hypertension (defined as a measured systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg under pharmacological control); 10. Malignant serous cavity effusion (e.g. pleural effusion, pericardial effusion, ascites); 11. Active bacterial, fungal or viral infections requiring intravenous infusion treatment within 1 week prior to the first dose; 12. Any anticancer treatment within 4 weeks prior to the first dose (e.g., radiotherapy, targeted therapy, immunotherapy, endocrine therapy, etc.); Traditional Chinese medicine or proprietary Chinese medicine with an approved oncology indication within 2 weeks prior to the first dose; 13. Enrolled in any other clinical trials within 4 weeks prior to the first dose; 14. Patients underwent major surgery within 12 weeks prior to the first dose, or have a surgical schedule during the study period; 15. Having a schedule of other anti-cancer treatment during the study period. 16. Deep vein thrombosis or arterial embolism within the previous 6 months, including but not limited to superior/inferior vena cava thrombosis, lower limb deep vein thrombosis, pulmonary embolism; 17. Lactating female; 18. Serious and/or uncontrolled medical condition that, in the judgment of the investigator, may affect the patient's participation in this study (including, but not limited to: diabetes not effectively controlled, kidney disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, neurological disorders, etc.); 19. Not suitable for this study as decided by the investigator due to other reasons.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record