Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-05 @ 6:21 PM
Study NCT ID:
NCT02043756
Status:
COMPLETED
Last Update Posted:
2014-01-23
First Post:
2014-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008942', 'term': 'Mitoxantrone'}], 'ancestors': [{'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome', 'timeFrame': '3 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mitoxantrone Hydrochloride Liposome Injection'], 'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '25034977', 'type': 'DERIVED', 'citation': 'Yang J, Shi Y, Li C, Gui L, Zhao X, Liu P, Han X, Song Y, Li N, Du P, Zhang S. Phase I clinical trial of pegylated liposomal mitoxantrone plm60-s: pharmacokinetics, toxicity and preliminary efficacy. Cancer Chemother Pharmacol. 2014 Sep;74(3):637-46. doi: 10.1007/s00280-014-2523-8. Epub 2014 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.', 'detailedDescription': 'The trial of the dose escalation method is from the minimum dose until the maximum tolerated dose and every 3 patient is a dose group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients must compliance with the requirements and restrictions listed in the consent form\n* Patients with Pathology and / or cytologically proven malignant solid tumor\n* Patients must be 18-70 years old ,both male and female\n* Failure of standard chemotherapy\n* Patients have no better choice and may be benefit from the use of anthracyclines\n* Patients must have Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2\n* Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks\n* Expected survival time ≥ 3 months\n* Patients agreed to take effective contraceptive measures during the trial\n* Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements.\n\nExclusion criteria:\n\n* Pregnancy and breast-feeding women\n* Multiple sclerosis\n* Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease\n* Patients with heart disease induced by anthracycline\n* Patients requiring other antineoplastic treatment\n* Patients with temperature above 38 degrees or active infection that may effects in clinical tests\n* Patients are allergic to anthracycline and liposomal drugs\n* Patients are allergic to eggs,egg products,soybean and soybean products\n* Patients with uncontrolled primary or metastatic brain tumors'}, 'identificationModule': {'nctId': 'NCT02043756', 'briefTitle': 'Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Solid Tumor', 'orgStudyIdInfo': {'id': 'cspcmitlip'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mitoxantrone Hydrochloride Liposome', 'description': 'Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart', 'interventionNames': ['Drug: Mitoxantrone Hydrochloride Liposome']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mitoxantrone ,injection', 'description': 'When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator', 'interventionNames': ['Drug: Mitoxantrone']}], 'interventions': [{'name': 'Mitoxantrone Hydrochloride Liposome', 'type': 'DRUG', 'otherNames': ['2010L04017'], 'description': '6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles', 'armGroupLabels': ['Mitoxantrone Hydrochloride Liposome']}, {'name': 'Mitoxantrone', 'type': 'DRUG', 'otherNames': ['Novantrone'], 'description': '10mg/m2, IV ,on day 1 of each 28 day,3 cycles', 'armGroupLabels': ['Mitoxantrone ,injection']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yuankai Shi, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701'}, {'name': 'Jianliang Yang, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788121'}, {'name': 'Xiaohong Han, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}