A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers

Recurrent Head and Neck Cancer Clinical Trial

Official title:

A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Recurrent/Metastatic Head and Neck Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902027
• Other study ID #: HE071-CSP-016
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Metastatic Head and Neck Cancer
• Recurrence
• Recurrent Head and Neck Cancer

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