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Unresectable or Metastatic Bone and Soft Tissue SarcomaPhase 1NCT04900766

A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Bone and Soft Tissue Sarcoma

A Phase 1 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Unresectable or Metastatic Bone and Soft Tissue Sarcoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with unresectable or metastatic bone and soft tissue sarcoma who has failed at least one prior line of therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mitoxantrone Hydrochloride Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
11 Aug 2021to 3 Feb 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Subjects fully understand and voluntarily participate in this study and sign informed consent; 2. Age ≥18 years, without gender limitation; 3. Histologically confirmed diagnosis of bone or soft tissue sarcoma; 4. Metastatic or unresectable bone or soft tissue sarcoma that has failed at least one prior line of therapy; 5. At least one measurable lesion according to RECIST v1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 7. Adequate organ function defined as:
  • Absolute neutrophil count (ANC) ≥1.5 x109/L (No G-CSF treatment within 1 week prior to the laboratory test);
  • Hemoglobin ≥ 110 g/L (No red blood cell transfusion within 1 week prior to the laboratory test);
  • Platelet count ≥ 100 x 109/L (No platelet transfusion within 1 week prior to the laboratory test);
  • Creatinine ≤1.5 x upper limit of normal (ULN);
  • Total bilirubin ≤1.5 x ULN (≤3.0 x ULN for liver metastasis);
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 3 x ULN (≤5.0 x ULN for liver metastasis);
  • Coagulation: Prothrombin time (PT) or International Normalization Ratio (INR) ≤1.5 x ULN (≤3.0 x for those receiving anticoagulant drugs such as warfarin); 8. Female subjects must have a urine or blood HCG negative test (except for menopause and hysterectomy); 9. Subjects and their partners must agree to use effective contraceptive measures during the study until 6 months after the end of the last dose.

Who cannot join

  • 1. History of severe allergy to mitoxantrone hydrochloride or liposomal drugs; 2. Cerebral or meningeal metastases; 3. History of allogeneic organ transplantation or allogeneic bone marrow transplantation; 4. Life expectancy < 12 weeks; 5. Subjects with chronic hepatitis B (HBsAg or HBcAb positive with HBV DNA ≥ 1000 IU/mL), hepatitis C (HCV antibody positive with HCV RNA above the lower limit of detection of the study center), or human immunodeficiency virus (HIV) antibody positive;; 6. AEs from the previous treatment > Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as alopecia, hyperpigmentation); 7. Active bacterial, fungal or viral infections that require systemic treatment within 1 week prior to the first dose; 8. Local or systemic anticancer treatment within 4 weeks prior to the first dose (within 2 weeks prior to dosing for traditional Chinese medicine or proprietary Chinese medicine); 9. Enrolled in any other clinical trials within 4 weeks prior to the first dose; 10. Thrombosis or thromboembolism within 6 months prior to screening; 11. History of, or known additional malignant tumor within 3 years, except for locally curable tumors that have been cured, such as basal or squamous cell skin cancer or in situ prostate, cervical or breast cancer; 12. Impaired cardiac function or serious cardiac disease:
  • Long QTc syndrome or QTc interval > 480 ms;
  • Complete left bundle branch block, II-III degree atrioventricular block;
  • Severe, uncontrolled arrhythmias requiring pharmacological treatment;
  • History of chronic congestive heart failure, NYHA ≥ grade 3;
  • Cardiac ejection fraction < 50% within 6 months prior to screening;
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  • Heart valve disease with CTCAE ≥ grade 3;
  • Uncontrollable hypertension (defined as a measured systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg under pharmacological control);
  • ECG evidence of myocardial infarction, unstable angina, history of severe pericardial disease, and acute ischemic or severe conduction system abnormalities within 6 months prior to screening; 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 medical condition that, in the judgment of the investigator, may affect the patient's participation in this study (including, but not limited to: diabetes not effectively controlled, kidney disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.); 16. Not suitable for this study as decided by the investigator due to other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100035

Other trials in China

About this study

Official title: A Multicenter, Open-label, Phase Ib Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Bone and Soft Tissue Sarcoma Who Has Failed At Least One Prior Line of Therapy

This is a multicenter, open-label, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with unresectable or metastatic bone and soft tissue sarcoma who has failed at least one prior line of therapy.

Read the detailed description

This is a multicenter, open-label, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with unresectable or metastatic bone and soft tissue sarcoma who has failed at least one prior line of therapy. About 50 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 the subjects will receive the treatment until disease progression, intolerable toxicity, death, or withdrawal by investigator or subject decision (a maximum of 6 cycles).

Being tested
Mitoxantrone Hydrochloride Liposome Injection
Medical subject headings
Sarcoma

What participants receive

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

  • Mitoxantrone Hydrochloride Liposome InjectionDrug

    20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

Study groups in NCT04900766
Study groupRoleWhat they receive
Mitoxantrone Hydrochloride Liposome InjectionExperimentalSubjects with unresectable or metastatic bone and soft tissue sarcoma will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome injection every 21 days (a cycle) for a maximum of 6 cycles.
Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection

What is being measured

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

  1. TEAEs

    Treatment-emergent adverse events

    Measured: From the initiation of the first dose to 28 days after the last dose

Secondary outcomes (5)

  1. ORR

    Overall response rate

    Measured: up to 36 months

  2. DoR

    Duration of response

    Measured: up to 36 months

  3. DCR

    disease control rate

    Measured: up to 36 months

  4. PFS

    progression-free survival

    Measured: up to 36 months

  5. OS

    overall survival

    Measured: 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 posted25 May 2021
  2. Study start11 Aug 2021
  3. Primary completion3 Feb 2023
  4. Study completion3 Feb 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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04900766
Sponsor's protocol ID
HE071-CSP-019
Status last verified
Feb 2024
First submitted
20 May 2021
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 Injection in people with Unresectable or Metastatic Bone and Soft Tissue Sarcoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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 8 inclusion and 10 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 1 site 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?

TEAEs (time frame: From the initiation of the first dose to 28 days after the last dose). 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 NCT04900766.

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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