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

Phase 1

Completed

• Conditions: Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer
• Interventions: Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

• Registration Number: NCT04902027
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief 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

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 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.

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-26
• Study Start: 2021-07-01
• Primary Completion: 2023-10-23
• Study Completion: 2023-10-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mitoxantrone Hydrochloride Liposome Injection	Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)	Subjects with Rrecurrent/metastatic Head and Neck Cancers will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles

Primary Outcome Measures

Name	Time	Method
adverse events (AEs),,graded according to the NCI CTCAE version 5.0	from the initiation of the first dose to 28 days after the last dose	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
(best total response) (BOR)	From the enrollment to the final documentation of response of the last subject ( at least 6 weeks between follow-up and enrolment	To investigate the preliminary antitumor efficacy
progression-free survival (PFS)	from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years	To investigate the preliminary antitumor efficacy
duration of response (DoR)	From the enrollment to CR, PR, PD, death, lost to follow-up, withdrawal, or study end, assessed up to 2 years	To investigate the preliminary antitumor efficacy
overall survival (OS)	from date of enrollment until date of first death from any cause, assessed up to 2 years	To investigate the preliminary antitumor efficacy

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China