Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04902027
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2021-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007275', 'term': 'Injections, Intravenous'}], 'ancestors': [{'id': 'D061605', 'term': 'Administration, Intravenous'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007267', 'term': 'Injections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adverse events (AEs),,graded according to the NCI CTCAE version 5.0', 'timeFrame': 'from the initiation of the first dose to 28 days after the last dose', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': '(best total response) (BOR)', 'timeFrame': 'From the enrollment to the final documentation of response of the last subject ( at least 6 weeks between follow-up and enrolment', 'description': 'To investigate the preliminary antitumor efficacy'}, {'measure': 'duration of response (DoR)', 'timeFrame': 'From the enrollment to CR, PR, PD, death, lost to follow-up, withdrawal, or study end, assessed up to 2 years', 'description': 'To investigate the preliminary antitumor efficacy'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': 'from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years', 'description': 'To investigate the preliminary antitumor efficacy'}, {'measure': 'overall survival (OS)', 'timeFrame': 'from date of enrollment until date of first death from any cause, assessed up to 2 years', 'description': 'To investigate the preliminary antitumor efficacy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Head and Neck Cancer', 'Metastatic Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects fully understand and voluntarily participate in this study and sign informed consent;\n2. . Age ≥18, female or male;\n3. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)\n4. Fail to respond to or progressed on at least one line of the standard therapy;\n5. At least one measurable lesion according to RECIST v1.1;\n6. ECOG performance status of 0 to 1;\n7. AEs from the previous treatment have resolved to ≤ Grade 1 based on\n\nExclusion Criteria:\n\n1. History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;\n2. Untreated or symptomatic central nervous system (CNS) metastases;\n3. History of allotransplantation;\n4. Life expectancy \\< 3 months\n5. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;\n6. Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;\n7. Use of other anticancer treatment within 4 weeks prior to the first dose administration;\n8. Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;\n9. Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;\n10. Thrombosis or thromboembolism within 6 months prior to screening;\n11. History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;\n12. Impaired cardiac function or serious cardiac disease\n13. Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is \\>350 mg/m2\n14. Pregnant or lactating female;\n15. Serious and/or uncontrolled systemic diseases;\n16. Not suitable for this study as decided by the investigator due to other reasons.'}, 'identificationModule': {'nctId': 'NCT04902027', 'briefTitle': 'A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HE071-CSP-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mitoxantrone Hydrochloride Liposome Injection', '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', 'interventionNames': ['Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)']}], 'interventions': [{'name': 'Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)', 'type': 'DRUG', 'description': 'All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).', 'armGroupLabels': ['Mitoxantrone Hydrochloride Liposome Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Zhiming Li, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cancer Prevention Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}