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

• Status: Recruiting
• Trial end date: 2024-01-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Mitoxantrone

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;