Back to resultsA Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers
Primary Purpose
Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- Not suitable for this study as decided by the investigator due to other reasons.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mitoxantrone Hydrochloride Liposome Injection
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
(best total response) (BOR)
To investigate the preliminary antitumor efficacy
duration of response (DoR)
To investigate the preliminary antitumor efficacy
progression-free survival (PFS)
To investigate the preliminary antitumor efficacy
overall survival (OS)
To investigate the preliminary antitumor efficacy
Full Information
NCT ID
NCT04902027
First Posted
March 18, 2021
Last Updated
May 20, 2021
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04902027
Brief Title
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mitoxantrone Hydrochloride Liposome Injection
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
Intervention Description
All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
Primary Outcome Measure Information:
Title
adverse events (AEs),,graded according to the NCI CTCAE version 5.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
from the initiation of the first dose to 28 days after the last dose
Secondary Outcome Measure Information:
Title
(best total response) (BOR)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to the final documentation of response of the last subject ( at least 6 weeks between follow-up and enrolment
Title
duration of response (DoR)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to CR, PR, PD, death, lost to follow-up, withdrawal, or study end, assessed up to 2 years
Title
progression-free survival (PFS)
Description
To investigate the preliminary antitumor efficacy
Time Frame
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Title
overall survival (OS)
Description
To investigate the preliminary antitumor efficacy
Time Frame
from date of enrollment until date of first death from any cause, assessed up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
Not suitable for this study as decided by the investigator due to other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefang Xia
Phone
010-63932012
Email
xiaxuefang@mail.ecspc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiming Li, MD
Phone
020-87343392
Email
lizhm@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiming Li, MD
Organizational Affiliation
Cancer Prevention Center, Sun Yat-sen University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers
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