Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-27 @ 7:05 PM
Study NCT ID:
NCT05089461
Status:
SUSPENDED
Last Update Posted:
2022-09-10
First Post:
2021-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'whyStopped': 'sponsor decided to stop', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2021-10-09', 'studyFirstSubmitQcDate': '2021-10-09', 'lastUpdatePostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac adverse event', 'timeFrame': 'up to approximately 5 years.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'up to approximately 3 years'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to approximately 3 years.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to approximately 5 years'}, {'measure': 'Incidence of treatment emergent adverse event (TEAE)', 'timeFrame': 'up to approximately 3 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Tumor']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, phase II study to evaluate the cardiac safety of Mitoxantrone Hydrochloride Liposome in patients with advanced malignant tumor who has received at least first-line treatment.', 'detailedDescription': "This is a multicenter, open-label, phase II study to evaluate the cardiac safety of Mitoxantrone Hydrochloride Liposome in patients with advanced malignant tumor who has received at least first-line treatment. About 120 patients will be recruited in this study. Patients with solid tumors will receive Mitoxantrone Hydrochloride Liposome 20 mg/m\\^2 by an intravenous infusion (IV) every 3 weeks (q3w, 1 cycle). Patients with lymphoma will receive Mitoxantrone Hydrochloride Liposome 20 mg/m\\^2 by an intravenous infusion (IV) every 4 weeks (q4w, 1 cycle). All the patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator's or patient's decision."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients fully understand and voluntarily participate in this study and sign informed consent;\n2. Age ≥18 years;\n3. Histologically confirmed diagnosis of late-stage solid tumor or peripheral T cell lymphoma (PTCL);\n4. Has received standard first-line treatment;\n5. Previous treated with anthracyclines, and converted to doxorubicin at equivalent doses. The cumulative dose of doxorubicin is 160 mg/m\\^2 \\< doxorubicin ≤550 mg/m\\^2;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;\n7. Adequate organ function:\n\n * Absolute neutrophil count (ANC) \\>1.5 10\\^9/L;\n * Hemoglobin \\> 90 g/L;\n * Platelet count \\> 75 10\\^9/L;\n * Creatinine \\< 1.5 upper limit of normal (ULN);\n * Total bilirubin \\< 1.5 ULN (\\< 3 ULN in patients with hepatic metastasis);\n * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\< 2.5 ULN (\\< 5 ULN in patients with hepatic metastasis);\n8. Patients of childbearing potential must agree to use effective contraceptive measures from screening until 6 months after the end of the last dose; Female patients must have a negative pregnancy test before enrolment.\n\nExclusion Criteria:\n\n1. History of allergy to mitoxantrone hydrochloride or liposomal drugs;\n2. Other malignant tumors in the past 3 years, excluding cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have been radically treated;\n3. Cerebral or meningeal metastases;\n4. HBsAg or HBcAb positive with HBV DNA ≥ 2000 IU/mL, HCV antibody positive with HCV RNA above the lower limit of detection of the study center, or human immunodeficiency virus (HIV) antibody positive;\n5. Life expectancy ≤ 12 weeks;\n6. AEs from the previous treatment \\> Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as alopecia, hyperpigmentation);\n7. Cardiac dysfunction, including:\n\n1)Long QT interval syndrome; 2)High-degree atrioventricular block; 3)Malignant arrhythmia poorly controlled by medication; 4)A history of chronic heart failure with NYHA≥3; 5)Severe heart valve regurgitation or stenosis requiring treatment; 6)Acute coronary syndrome, severe pericardial disease, severe myocardial disease within 6 months prior to screening; 7)Poorly controlled hypertension (defined as systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than100 mmHg, measured ≥3 times, under control of antihypertensive drug); 8)Echocardiography showed LVEF \\< 50%; 8.Active bacterial or fungal infection requiring systemic intravenous therapy within 1 week before the first dose; 9.Use of other anticancer treatment within 4 weeks prior to the first dose; 10.Enrolled in any other clinical trials within 4 weeks prior to the first dose; 11.Patients underwent major surgery within 3 months prior to the first dose, or have a surgical schedule during the study period;; 12.Thrombosis or thromboembolism within 6 months prior to the first dose; 13.Lactating female; 14.Serious and/or uncontrolled systemic diseases; 15.Not suitable for this study as decided by the investigator due to other reasons.'}, 'identificationModule': {'nctId': 'NCT05089461', 'briefTitle': 'A Study to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'An Open-label, Multi-center Phase II Clinical Trial to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor', 'orgStudyIdInfo': {'id': 'HE071-CSP-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mitoxantrone Hydrochloride Liposome Injection', 'description': 'Patients with advanced malignant tumor will receive 20 mg/m\\^2 Mitoxantrone Hydrochloride Liposome by an intravenous infusion (IV) on day 1 of each treatment cycle.', 'interventionNames': ['Drug: Mitoxantrone Hydrochloride Liposome']}], 'interventions': [{'name': 'Mitoxantrone Hydrochloride Liposome', 'type': 'DRUG', 'description': 'Mitoxantrone Hydrochloride Liposome, intravenous injection (IV), 20 mg/m\\^2. Solid tumors: every 3 weeks (q3w, 1 cycle), Lymphoma: every 4 weeks (q4w, 1 cycle).', 'armGroupLabels': ['Mitoxantrone Hydrochloride Liposome Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116011', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'the first affiliated hospital of Dalian medical university', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}