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

Advanced Gastric Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04718402
• Other study ID #: HE071-CSP-014
• Status: Terminated
• Phase: Phase 1
• Start date: March 30, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: May 2021
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Gastric Carcinoma
• Carcinoma
• Stomach Neoplasms

Intervention

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).

Locations

Country	Name	City	State
China	Beijing Luhe Hospital Capital Medical University	Beijing	Beijing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Cancer Hospital of The University of Chinese Academy of Science	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital	Shijiazhuang	Hebei
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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