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

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04902027
Collaborator
(none)
30
Enrollment
1
Arm
33
Anticipated Duration (Months)

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 DiseaseIntervention/TreatmentPhase
  • Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
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

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

ArmIntervention/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

  1. 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

  1. (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

  2. 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

  3. 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

  4. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

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.
Responsible Party:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04902027
Other Study ID Numbers:
  • HE071-CSP-016
First Posted:
May 26, 2021
Last Update Posted:
May 26, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2021