A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: 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).
|
Outcome Measures
Primary Outcome Measures
- 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
- (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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects fully understand and voluntarily participate in this study and sign informed consent;
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. Age ≥18, female or male;
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Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
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Fail to respond to or progressed on at least one line of the standard therapy;
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At least one measurable lesion according to RECIST v1.1;
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ECOG performance status of 0 to 1;
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AEs from the previous treatment have resolved to ≤ Grade 1 based on
Exclusion Criteria:
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History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
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Untreated or symptomatic central nervous system (CNS) metastases;
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History of allotransplantation;
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Life expectancy < 3 months
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Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
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Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
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Use of other anticancer treatment within 4 weeks prior to the first dose administration;
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Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;
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Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
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Thrombosis or thromboembolism within 6 months prior to screening;
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History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
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Impaired cardiac function or serious cardiac disease
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Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2
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Pregnant or lactating female;
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Serious and/or uncontrolled systemic diseases;
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Not suitable for this study as decided by the investigator due to other reasons.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
- Study Chair: Zhiming Li, MD, Cancer Prevention Center, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HE071-CSP-016