Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT01909856
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2013-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077924', 'term': 'Palonosetron'}, {'id': 'D017829', 'term': 'Granisetron'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2013-07-22', 'studyFirstSubmitQcDate': '2013-07-24', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response(CR) within 24-120 hours after chemotherapy', 'timeFrame': '24-120 hours'}], 'secondaryOutcomes': [{'measure': 'CR within 0-120 hours after chemotherapy', 'timeFrame': '0-120 hours'}, {'measure': 'CR within 0-24 hours after chemotherapy', 'timeFrame': '0-24 hours'}, {'measure': 'Incidence of Adverse events', 'timeFrame': 'up to 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;\n* The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;\n* Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;\n* Life expectancy ≥ 3 months;\n* Adequate hematologic function;\n* Adequate hepatic function;\n* Adequate renal function;\n* At least 2 weeks away from the last chemotherapy;\n* Patients signed written informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating women;\n* History of anticipatory vomiting;\n* Radiation therapy on the abdomen or pelvis within one week prior to study entry;\n* Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);\n* Patients with gastrointestinal obstruction;\n* Patients with severe heart disease, liver or renal disease, or metabolism disorders;\n* Patients with epilepsy or using sedative or psychotropic drugs;\n* Patients with diabetes or with contraindication for corticosteroids;\n* Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry;\n* Patients with brain metastasis or intracranial hypertension;\n* Hypersensitivity to 5-HT3 receptor antagonist;\n* Patients with active infection;\n* Other conditions that the investigator considered as unsuitable for chemotherapy;\n* Subjects participating in other clinical trials.'}, 'identificationModule': {'nctId': 'NCT01909856', 'briefTitle': 'The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Simcere Pharmaceutical Co., Ltd.'}, 'officialTitle': 'The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy', 'orgStudyIdInfo': {'id': 'sim-palonosetron'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm1', 'description': '1st cycle Palonosetron, 2nd cycle Granisetron', 'interventionNames': ['Drug: Palonosetron', 'Drug: Granisetron', 'Drug: Dexamethasone', 'Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm2', 'description': '1st cycle Granisetron, 2nd cycle Palonosetron', 'interventionNames': ['Drug: Palonosetron', 'Drug: Granisetron', 'Drug: Dexamethasone', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Palonosetron', 'type': 'DRUG', 'description': 'Palonosetron 0.25mg d1,d3', 'armGroupLabels': ['Arm1', 'Arm2']}, {'name': 'Granisetron', 'type': 'DRUG', 'description': 'Granisetron 3mg d1-3', 'armGroupLabels': ['Arm1', 'Arm2']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 10mg d1-3', 'armGroupLabels': ['Arm1', 'Arm2']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3', 'armGroupLabels': ['Arm1', 'Arm2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Shiying Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Simcere Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}