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TerminatedNCT04718376Updated Mar 7, 2024

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

A Phase 1 interventional study of Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) in Platinum-resistant Ovarian Cancer, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Terminated at 7 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 1, Interventional, and Treatment

Why this study was terminated
The sponsor has adjusted its R\&D strategy.
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Platinum-resistant Ovarian Cancer

Keywords

  • platinum-refractory, platinum-resistant, ovarian cancer
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 56 is close to the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 161 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • 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)

Interventions

  • DrugMitoxantrone 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).

06

What researchers measure

Primary outcomes

  1. adverse events (AEs)

    The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).

    Time frame: from the initiation of the first dose to 28 days after the last dose，assessed up to 36 months

Secondary outcomes

  1. overall response rate (ORR)

    To investigate the preliminary antitumor efficacy

    Time frame: From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)

  2. duration of response (DoR)

    To investigate the preliminary antitumor efficacy

    Time frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months

  3. duration of complete response (DCR)

    To investigate the preliminary antitumor efficacy

    Time frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months

  4. progression-free survival (PFS)

    To investigate the preliminary antitumor efficacy

    Time frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months

  5. overall survival (OS)

    To investigate the preliminary antitumor efficacy

    Time frame: From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months)

07

Study locations

7 sites
  • Chongqing University Cancer Hospital
    Chongqing, Chongqing 400030, China
  • Fujian Cancer Hospital
    Fuzhou, Fujian 350014, China
  • Guangxi Medical University Cancer Hospital
    Nanning, Guangxi 530021, China
  • Guizhou Cancer Hospital
    Guiyang, Guizhou 550000, China
  • Harbin Medical University Hospital
    Harbin, Heilongjiang 150081, China
  • Henan Cancer Hospital
    Zhengzhou, Henan 450000, China
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04718376
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Jan 22, 2021
Start date
Jan 12, 2021
Primary completion
May 22, 2023
Completion
May 22, 2023
Last update
Mar 7, 2024

Study contacts

Qi Zhou, Master
principal investigator · Chongqing University Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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