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

NCT04902027 | Completed Phase 1

• 1 other identifier: HE071-CSP-016
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• (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

• 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

• 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

• overall survival (OS)

  from date of enrollment until date of first death from any cause, assessed up to 2 years

Study Arms (1)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

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

Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

Interventions

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) DRUG

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

Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects fully understand and voluntarily participate in this study and sign informed consent;
• Age ≥18, female or male;
• Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
• Fail to respond to or progressed on at least one line of the standard therapy;
• At least one measurable lesion according to RECIST v1.1;
• ECOG performance status of 0 to 1;
• AEs from the previous treatment have resolved to ≤ Grade 1 based on

You may not qualify if:

• History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
• Untreated or symptomatic central nervous system (CNS) metastases;
• History of allotransplantation;
• Life expectancy \< 3 months
• Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
• Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
• Use of other anticancer treatment within 4 weeks prior to the first dose administration;
• Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;
• Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
• Thrombosis or thromboembolism within 6 months prior to screening;
• History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
• Impaired cardiac function or serious cardiac disease
• Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is \>350 mg/m2
• Pregnant or lactating female;
• Serious and/or uncontrolled systemic diseases;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Injections, Intravenous

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections

Study Officials

• Zhiming Li, MD

  Cancer Prevention Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: May 26, 2021
• Study Start: July 1, 2021
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-02

Locations

CN (1)