A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian Cancer

NCT ID: NCT04718376

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2023-05-22

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 Relapsed Ovarian Cancer.

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 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.

Conditions

Platinum-resistant Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mitoxantrone Hydrochloride Liposome Injection

Subjects with Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles.

Group Type: EXPERIMENTAL

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

Intervention Type: DRUG

All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

Interventions

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qi Zhou, Master

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Guizhou Cancer Hospital

Guiyang, Guizhou, China

Harbin Medical University Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

HE071-CSP-015

Identifier Type: -

Identifier Source: org_study_id