a study of mitoxantrone hydrochloride liposome injection in the treatment of relapsed ovarian cancer

Conditions: Platinum-resistant Ovarian Cancer

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 relapsed ovarian cancer.

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 relapsed ovarian cancer. 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). delays in drug administration is allowed from the cycle 2, however, the delays should be no more than 3 weeks. dose adjustments after the cycle 2 is permitted, and the minimum dose is 12mg/m2.

Eligibility criteria:
inclusion criteria: 1. subjects fully understand and voluntarily participate in this study and sign informed consent; 2. age ≥18, female; 3. histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma (excluding low grade serous carcinoma and mucous carcinoma); 4. fail to respond to or progressed on the standard platinum-based therapy ; 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. pericardial effusion with clinical symptoms 4. history of allotransplantation; 5. known hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv) or other active viral infection; 6. serious infection or interstitial pneumonia within 1 week prior to the first dose administration; 7. use of other anticancer treatment within 4 weeks prior to the first dose administration; 8. enrolled in any other clinical trials within 4 weeks prior to the first dose administration; 9. major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period; 10. thrombosis or thromboembolism within 6 months prior to screening; 11. history of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ; 12. impaired cardiac function or serious cardiac disease; 13. previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is \>350 mg/m2. 14. pregnant or lactating female; 15. serious and/or uncontrolled systemic diseases; 16. not suitable for this study as decided by the investigator due to other reasons.

Keywords: platinum-refractory, platinum-resistant, ovarian cancer