Status:
TERMINATED
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian Cancer
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Platinum-resistant Ovarian Cancer
Eligibility:
FEMALE
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 Platinum-Resistant or Platinum-Refractory Rela...
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 Platinum-Resistant or Platinum-Refractory Rela...
Eligibility Criteria
Inclusion
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- Age ≥18, female;
- Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma (excluding low grade serous carcinoma and mucous carcinoma);
- Fail to respond to or progressed on the standard platinum-based therapy ;
- 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;
- Pericardial effusion with clinical symptoms
- 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.
- 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 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04718376
Start Date
January 12 2021
End Date
May 22 2023
Last Update
March 7 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
2
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
3
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
4
Guizhou Cancer Hospital
Guiyang, Guizhou, China, 550000