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

NCT ID: NCT04902027

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-10-23

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.

Conditions

Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mitoxantrone Hydrochloride Liposome Injection

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

Group Type: EXPERIMENTAL

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

Intervention Type: DRUG

All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiming Li, MD

Role: STUDY_CHAIR

Cancer Prevention Center, Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

HE071-CSP-016

Identifier Type: -

Identifier Source: org_study_id