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

NCT05100329 | Unknown Phase 2

• 1 other identifier: HE071-CSP-026
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall survival (OS)

  Up to approximately 3 years

• Progression-free survival (PFS)

  Up to approximately 3 years

• Disease control rate (DCR)

  Up to approximately 3 years

• Duration of response (DoR)

  Up to approximately 3 years

• Treatment-emergent adverse events (TEAEs)

  Up to approximately 3 years

Study Arms (1)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

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

Drug: Mitoxantrone Hydrochloride Liposome injection

Interventions

Mitoxantrone Hydrochloride Liposome injection DRUG

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

Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients fully understand and voluntarily participate in this study and sign informed consent;
• Aged 18-75 years (inclusive), without gender limitation;
• Histologically or cytologically confirmed advanced pancreatic tumors;
• Patients with locally progressive or metastatic pancreatic cancer who have disease progression after receiving first line or above standard treatment.
• At least one measurable lesion according to RECIST v1.1 at baseline;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
• 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;
• 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.
• 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.

You may not qualify if:

• History of severe allergy to mitoxantrone hydrochloride or any excipients of the study drug;
• History of other malignant tumor in previous 3 years, not including cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma.
• Cerebral or meningeal metastases;
• 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;
• Life expectancy \< 3 months;
• Previous treatment with adriamycin or other anthracyclines, with the total cumulative dose (doxorubicin equivalent) \>350 mg/m\^2;
• 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);
• 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;
• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Central Study Contacts

Xuefang Xia

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: May 1, 2024
• Last Updated: October 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share