Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-31 @ 2:26 AM
Study NCT ID:
NCT04482257
Status:
UNKNOWN
Last Update Posted:
2020-07-22
First Post:
2020-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2020-07-20', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '0 -190 hours', 'description': 'Cmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen).'}, {'measure': 'AUC0-t', 'timeFrame': '0 -190 hours', 'description': 'The exposure of Total Irinotecan and Free Irinotecan from time (0) to the last quantifiable concentration (t) will be measured for the test product (CSPC) or the reference product (Ipsen).'}, {'measure': 'AUC0-∞', 'timeFrame': '0 -190 hours', 'description': 'The exposure of Total Irinotecan and Free Irinotecan from time (0) to infinity (∞) will be calculated for the test product (CSPC) or the reference product (Ipsen).'}, {'measure': 'Tmax', 'timeFrame': '0 -190 hours', 'description': 'The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).'}, {'measure': 't1/2', 'timeFrame': '0 -190 hours', 'description': 'The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen).'}, {'measure': 'λz', 'timeFrame': '0 -190 hours', 'description': 'The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.', 'detailedDescription': 'The purpose of this study was to determine the bioequivalence of two formulations of Irinotecan Liposome Injection (70mg/m2) in Chinese patients with Advanced Pancreatic Cancer, under fasting condition. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent for participation in the trial.\n2. Advanced pancreatic cancer diagnosed by histopathology and / or cytology.\n3. Age ≥ 18 years, men or women. BMI is above 17.\n4. ECOG score 0 to 2.\n5. Life expectancy ≥ 3 months.\n6. Adequate bone marrow function.\n7. Adequate hepatic function.\n8. Adequate renal function.\n9. Patient with reproductive potential must agree to use adequate contraception from the signing of informed consent to at least 6 months after the trial\n\nExclusion Criteria:\n\n1. Patients who have a severe allergy or a significant history of hypersensitivity or an idiopathic reaction attributed to irinotecan or compounds of similar chemical composition to irinotecan ;\n2. Patients who have previously used irinotecan liposomes and experienced treatment failure or serious adverse reactions;\n3. Patients with severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric diseases that occurred within 3 months of the first dose of the study drug, and not suitable for this study as determined by the researchers;\n4. Patients who have undergone major surgery within 4 weeks of screening or have a schedule for major surgery during the study period;\n5. Patients who have received any radiotherapy or chemotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug, traditional Chinese medicine with anti-tumor indications within 4 weeks of the first dose of the study drug, or small molecule targeted drugs within 2 weeks (or 5 half-lives whichever is longer) of the first dose of the study drug;\n6. Patients who currently enrolled in any other clinical study, or received other investigational agents within 4 weeks of the first dose of the study drug；\n7. Blood donation or massive blood loss (\\>400mL) within 90 days of screening;\n8. Concomitant use of strong CYP3A4 inhibitors or inducers, or UGT1A1 inhibitors within 4 weeks of the first dose of the study drug;\n9. Patients who received certain diet (such as grapefruit) which may interfere with the evaluation of PK results;\n10. LVEF≤50%;\n11. Patients with extended QT/QTc interval (QTcF\\>480ms);\n12. History of alcohol or drugs abuse;\n13. Pregnant or lactating women;\n14. Patients with known Hepatitis B Virus (HBV DNA≥104), Hepatitis C Virus (anti-HCV positive, HCV RNA positive), Human immunodeficiency virus antibody (anti-HIV positive), or active Treponema Pallidum viral infection;\n15. Patients with homozygous UGT1A1\\*28 genotype or UGT1A1\\*6 genotype;\n16. Patients who are not suitable for this study as determined by the researchers.'}, 'identificationModule': {'nctId': 'NCT04482257', 'briefTitle': 'Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC Ouyi Pharmaceutical Co., Ltd.'}, 'officialTitle': '*Official Title: Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.', 'orgStudyIdInfo': {'id': 'HE072-BE-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T-R', 'description': 'Subjects will receive Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV', 'interventionNames': ['Drug: Irinotecan Liposome Injection combined with 5-FU/LV']}, {'type': 'EXPERIMENTAL', 'label': 'R-T', 'description': 'Subjects will receive Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV', 'interventionNames': ['Drug: Irinotecan Liposome Injection combined with 5-FU/LV']}], 'interventions': [{'name': 'Irinotecan Liposome Injection combined with 5-FU/LV', 'type': 'DRUG', 'description': 'Drug: Irinotecan Liposome Injection 70mg/m2 (CSPC) combined with 5-FU/LV; Drug: Irinotecan Liposome Injection 70mg/m2 (Ipsen, ONIVYDETM) combined with 5-FU/LV;', 'armGroupLabels': ['R-T', 'T-R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tianqiang Song', 'role': 'CONTACT', 'email': 'ec_tjcih@126.com', 'phone': '022-23340123', 'phoneExt': '6012'}], 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'xuekun Yao', 'role': 'CONTACT', 'email': 'yaoxuekun@mail.ecspc.com', 'phone': '0311-67808678'}], 'overallOfficials': [{'name': 'Jihui Hao, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC Ouyi Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}