Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
Conditions
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.
Interventions
All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| (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 |
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed