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

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04900766
Collaborator
(none)
50
Enrollment
1
Arm
24
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Mitoxantrone Hydrochloride Liposome Injection
Phase 1

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Mitoxantrone Hydrochloride Liposome Injection

Subjects 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.

Drug: Mitoxantrone Hydrochloride Liposome Injection
20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

Outcome Measures

Primary Outcome Measures

  1. TEAEs [From the initiation of the first dose to 28 days after the last dose]

    Treatment-emergent adverse events

Secondary Outcome Measures

  1. ORR [up to 36 months]

    Overall response rate

  2. DoR [up to 36 months]

    Duration of response

  3. DCR [up to 36 months]

    disease control rate

  4. PFS [up to 36 months]

    progression-free survival

  5. OS [up to 36 months]

    overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    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.

Exclusion Criteria:
    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;

  • 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.

  1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Principal Investigator: Xiaohui Niu, Bachelor, Beijing Jishuitan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04900766
Other Study ID Numbers:
  • HE071-CSP-019
First Posted:
May 25, 2021
Last Update Posted:
May 25, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2021