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

March 5, 2024 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Chongqing University Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian cancer hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Guangxi Medical University Cancer Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Guizhou Cancer Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Hospital
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events (AEs)
Time Frame: from the initiation of the first dose to 28 days after the last dose，assessed up to 36 months
The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).
from the initiation of the first dose to 28 days after the last dose，assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate (ORR)
Time Frame: From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
To investigate the preliminary antitumor efficacy
From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
duration of response (DoR)
Time Frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
To investigate the preliminary antitumor efficacy
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
progression-free survival (PFS)
Time Frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
To investigate the preliminary antitumor efficacy
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
duration of complete response (DCR)
Time Frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
To investigate the preliminary antitumor efficacy
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
overall survival (OS)
Time Frame: From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months)
To investigate the preliminary antitumor efficacy
From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Principal Investigator: Qi Zhou, Master, Chongqing University Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Actual)

May 22, 2023

Study Completion (Actual)

May 22, 2023

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE071-CSP-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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