Status:
UNKNOWN
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Solid Tumor
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multicenter, randomized, open-label, phase Ib study to evaluate the safety, efficacy and pharmacokinetic characteristics of Mitoxantrone Hydrochloride Liposome in subjects with advanced soli...
Detailed Description
This is a multicenter, randomized, open-label, phase Ib study to evaluate the safety, efficacy and pharmacokinetic characteristics of Mitoxantrone Hydrochloride Liposome in subjects with advanced soli...
Eligibility Criteria
Inclusion
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- Age ≥18, without gender limitation;
- Histologically and/or cytologically confirmed diagnosis of unresectable local or metastasizing advanced solid tumor;
- Fail to respond to standard therapy or lack of effective treatment, including no standard therapy, intolerance of standard therapy, etc.;
- At least one measurable lesion according to RECIST v1.1;
- ECOG performance status of 0 or 1;
- 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 enrollment;
- 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;
- 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 trials 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;
- Life expectancy\<12 weeks;
- Pregnant or lactating female;
- Serious and/or uncontrolled systemic diseases;
- Not suitable for this study as decided by the investigator due to other reasons.
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 13 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04719065
Start Date
January 13 2021
End Date
April 13 2024
Last Update
November 1 2021
Active Locations (8)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233099
2
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 511399
3
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550000
4
Affiliated Hospital of Hebei University
Baoding, Hebei, China