Status:
TERMINATED
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Advanced Gastric Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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 subjec...
Eligibility Criteria
Inclusion
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- Age ≥18, without gender limitation;
- Histologically confirmed diagnosis of unresectable locally advanced or metastatic gastric carcinoma, including gastroesophageal junction carcinoma;
- Suitable to receive the study drug as decided by the investigator;
- At least one measurable lesion according to RECIST v1.1;
- ECOG performance status of 0 to 2;
- Life expectancy ≥ 12 weeks;
- 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);
- Adequate organ function;
- Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrolment;
- Fully comply with the protocol.
Exclusion
- History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
- Untreated or symptomatic central nervous system (CNS) metastases;
- Amenable to curative surgery ( radical excision);
- 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);
- Intestinal obstruction with overt clinical symptom and requiring treatment;
- CTCAE Grade 3 or Grade 4 gastrointestinal hemorrhage within 12 weeks prior to the first dose administration;
- History of allotransplantation;
- Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
- Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
- Use of other anticancer treatment within 4 weeks prior to the first dose administration;
- Enrolled in any other clinical trails and had recieved treatment within 4 weeks prior to the first dose administration;
- Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
- Thrombosis or thromboembolism within 6 months prior to screening;
- History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
- Impaired cardiac function or serious cardiac disease;
- Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is \>350 mg/m2.
- Pregnant or lactating female;
- Serious and/or uncontrolled systemic diseases;
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04718402
Start Date
March 30 2021
End Date
May 30 2022
Last Update
March 7 2024
Active Locations (9)
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1
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, China, 101149
2
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350011
3
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
4
Hebei General Hospital
Shijiazhuang, Hebei, China, 050000