A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma

A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Gastric Carcinoma

This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with advanced gastric carcinoma.

Study Overview

• Status: Terminated
• Conditions: Advanced Gastric Carcinoma
• Intervention / Treatment: Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection

Detailed Description

This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with advanced gastric carcinoma. At least 30 subjects will be recruited in this study. The subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle). All patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator or patient decision (a maximum of 8 cycles).

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 101149
      • Beijing Luhe Hospital Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350011
      • Fujian Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Hebei General Hospital
    • Shijiazhuang, Hebei, China, 050019
      • The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310022
      • Cancer Hospital of The University of Chinese Academy of Science
    • Taizhou, Zhejiang, China, 317000
      • Taizhou Hospital of Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent;
2. Age ≥18, without gender limitation;
3. Histologically confirmed diagnosis of unresectable locally advanced or metastatic gastric carcinoma, including gastroesophageal junction carcinoma;
4. Suitable to receive the study drug as decided by the investigator;
5. At least one measurable lesion according to RECIST v1.1;
6. ECOG performance status of 0 to 2;
7. Life expectancy ≥ 12 weeks;
8. AEs from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as hair loss, hyperpigmentation);
9. Adequate organ function;
10. Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrolment;
11. Fully comply with the protocol.

Exclusion Criteria:

1. History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
2. Untreated or symptomatic central nervous system (CNS) metastases;
3. Amenable to curative surgery ( radical excision);
4. Pleural effusion, pericardial effusion or peritoneal effusion with overt clinical symptoms (except for those have a drainage within 1 month before screening, asymptomatic and the effusion only detectable by imageological examination);
5. Intestinal obstruction with overt clinical symptom and requiring treatment;
6. CTCAE Grade 3 or Grade 4 gastrointestinal hemorrhage within 12 weeks prior to the first dose administration;
7. History of allotransplantation;
8. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
9. Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
10. Use of other anticancer treatment within 4 weeks prior to the first dose administration;
11. Enrolled in any other clinical trails and had recieved treatment within 4 weeks prior to the first dose administration;
12. Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
13. Thrombosis or thromboembolism within 6 months prior to screening;
14. History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
15. Impaired cardiac function or serious cardiac disease;
16. Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2.
17. Pregnant or lactating female;
18. Serious and/or uncontrolled systemic diseases;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mitoxantrone Hydrochloride Liposome Injection; Subjects with advanced gastric carcinoma will receive 20mg/m2Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles.	Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection; All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events (AEs)	The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).	From the initiation of the first dose to 28 days after the last dose, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate (ORR)	To investigate the preliminary antitumor efficacy	From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
duration of response (DoR)	To investigate the preliminary antitumor efficacy	From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
duration of complete response (DCR)	To investigate the preliminary antitumor efficacy	From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
progression-free survival (PFS)	To investigate the preliminary antitumor efficacy	From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
overall survival (OS)	To investigate the preliminary antitumor efficacy	From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Principal Investigator: Jieer Ying, Doctor, Cancer Hospital of The University of Chinese Academy of Science

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Mitoxantrone
• Other Study ID Numbers: HE071-CSP-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No