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
Verified date | February 2024 |
Source | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
China,
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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