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Platinum-resistant Ovarian CancerPhase 1NCT04718376

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

A Phase 1 study testing Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) in people with Platinum-resistant Ovarian Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 7 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Platinum-resistant Ovarian Cancer
What is being tested?
Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
7 sitesChina
Study dates
12 Jan 2021to 22 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Guizhou Cancer Hospital

    Guiyang, Guizhou, 550000

  • Harbin Medical University Hospital

    Harbin, Heilongjiang, 150081

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

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

    Wuhan, Hubei, 430022

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: 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.

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.

Being tested
Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
Keywords
platinum-refractory, platinum-resistant, ovarian cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)Drug

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

Study groups in NCT04718376
Study groupRoleWhat they receive
Mitoxantrone Hydrochloride Liposome InjectionExperimentalSubjects 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.
Receives: Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (5)

  1. overall response rate (ORR)

    To investigate the preliminary antitumor efficacy

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start12 Jan 2021
  3. Primary completion22 May 2023
  4. Study completion22 May 2023

Why it stopped: The sponsor has adjusted its R\&D strategy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04718376
Sponsor's protocol ID
HE071-CSP-015
Status last verified
May 2021
First submitted
14 Dec 2020
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) in people with Platinum-resistant Ovarian Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The sponsor has adjusted its R\&D strategy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events (AEs) (time frame: from the initiation of the first dose to 28 days after the last dose，assessed up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04718376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.

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