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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04718402
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Carcinoma Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : January 19, 2022
Estimated Study Completion Date : January 19, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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).


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


Secondary Outcome Measures :
  1. overall response rate (ORR) [ Time Frame: From the enrollment to the final documentation of response of the last subject (assessed up to 36 months) ]
    To investigate the preliminary antitumor efficacy

  2. duration of response (DoR) [ Time Frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months ]
    To investigate the preliminary antitumor efficacy

  3. duration of complete response (DCR) [ Time Frame: From the enrollment to the final documentation of response of the last subject (assessed up to 36 months) ]
    To investigate the preliminary antitumor efficacy

  4. progression-free survival (PFS) [ Time Frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months ]
    To investigate the preliminary antitumor efficacy

  5. overall survival (OS) [ Time Frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months ]
    To investigate the preliminary antitumor efficacy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04718402


Contacts
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Contact: Xuefang Xia 010-63932012 xiaxuefang@mail.ecspc.com

Locations
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China, Beijing
Beijing Luhe Hospital Capital Medical University Recruiting
Beijing, Beijing, China, 101149
Contact: Dong Yan, Doctor    13621308215    yd15yt88@163.com   
Principal Investigator: Dong Yan, Doctor         
China, Fujian
Fujian Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350011
Contact: Rongbo Lin, Bachelor    13705919382    rongbo_lin@163.com   
Principal Investigator: Rongbo Lin, Bachelor         
China, Gansu
Lanzhou University Second Hospital Recruiting
Lanzhou, Gansu, China, 730030
Contact: Hao Chen, MD    15009467790    chenhaodrs@163.com   
Principal Investigator: Hao Chen, MD         
China, Hebei
Hebei General Hospital Not yet recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Qingxia Li, MD    13613110158    lqx73@163.com   
Principal Investigator: Qingxia Li, MD         
The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital Not yet recruiting
Shijiazhuang, Hebei, China, 050019
Contact: Ruixing Zhang, MD    13831120299    zrx@medmail.com.cn   
Principal Investigator: Ruixing Zhang, MD         
Principal Investigator: Qun Zhao, MD         
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Jufeng Wang, Master    13783583966    13783583966@163.com   
Principal Investigator: Jufeng Wang, Master         
China, Zhejiang
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310014
Contact: Liu Yang, MD    13666601475    yangliuqq2003@163.com   
Principal Investigator: Liu Yang, MD         
Cancer Hospital of The University of Chinese Academy of Science Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Jieer Ying, MD    13858195803    jieerying@aliyun.com   
Principal Investigator: Jieer Ying, MD         
Taizhou Hospital of Zhejiang Province Not yet recruiting
Taizhou, Zhejiang, China, 317000
Contact: Jianying Jin, Master    13867656027    302861459@qq.com   
Principal Investigator: Jianying Jin, Master         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Jieer Ying, Doctor Cancer Hospital of The University of Chinese Academy of Science
More Information
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04718402    
Other Study ID Numbers: HE071-CSP-014
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Mitoxantrone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action