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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04902027
Other study ID # HE071-CSP-016
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 1, 2021
Est. completion date October 23, 2023

Study information

Verified date February 2024
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 recurrent/metastatic Head and Neck Cancers


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 recurrent/metastatic head and neck cancers. 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 withdrawa 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date October 23, 2023
Est. primary completion date October 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects fully understand and voluntarily participate in this study and sign informed consent; 2. . Age =18, female or male; 3. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) 4. Fail to respond to or progressed on at least one line of the standard therapy; 5. At least one measurable lesion according to RECIST v1.1; 6. ECOG performance status of 0 to 1; 7. AEs from the previous treatment have resolved to = Grade 1 based on 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. History of allotransplantation; 4. Life expectancy < 3 months 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 Design


Intervention

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).

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary adverse events (AEs),,graded according to the NCI CTCAE version 5.0 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 from the initiation of the first dose to 28 days after the last dose
Secondary (best total response) (BOR) To investigate the preliminary antitumor efficacy From the enrollment to the final documentation of response of the last subject ( at least 6 weeks between follow-up and enrolment
Secondary duration of response (DoR) To investigate the preliminary antitumor efficacy From the enrollment to CR, PR, PD, death, lost to follow-up, withdrawal, or study end, assessed up to 2 years
Secondary progression-free survival (PFS) To investigate the preliminary antitumor efficacy from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Secondary overall survival (OS) To investigate the preliminary antitumor efficacy from date of enrollment until date of first death from any cause, assessed up to 2 years
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