Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-11 @ 3:19 AM
Study NCT ID:
NCT02400866
Status:
UNKNOWN
Last Update Posted:
2015-03-27
First Post:
2015-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Study of Olanzapine for the Prevention of CINV in Patients Receiving Moderately Emetogenic Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-26', 'studyFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response rate for the acute phase (0-24 hours) after chemotherapy', 'timeFrame': 'during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC)'}], 'secondaryOutcomes': [{'measure': 'complete response rate for the delayed phase (24-120 hours) and overall phase (0-120 hours) after chemotherapy', 'timeFrame': 'during 0-120 hours after first cycle of MEC'}, {'measure': 'no vomiting for the overall phase', 'timeFrame': 'during 0-120 hours after first cycle of MEC'}, {'measure': 'significant emesis for the overall phase', 'timeFrame': 'during 0-120 hours after first cycle of MEC'}, {'measure': 'numbers and time for rescue medicaions', 'timeFrame': 'during 0-120 hours after first cycle of MEC'}, {'measure': 'effects on quality of life by FLIE questionnaire', 'timeFrame': 'during 0-120 hours after first cycle of MEC'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer patients receiving moderately emetogenic chemotherapy'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy by a randomized, double-blind, placebo-controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 19 years of age\n* no history of receiving moderately or highly emetogenic chemotherapy during last 6 months, and is to receive a first course of MEC including one or more of following agents: Carboplatin, Cyclophosphamide ≤ 1,500 mg/m2, Daunorubicin, Doxorubicin \\< 60 mg/m2, Epirubicin ≤ 90 mg/m2, Irinotecan, Oxaliplatin, Melphalan, Methotrexate ≥ 250 mg/m2\n* ECOG performance status 0-2\n* predicted life expectancy ≥ 3 months\n* adequate bone marrow, kidney, and liver functionas evidenced by: ANC ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, total bilirubine ≤ 2 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN (for subjects with known liver metastases, total bilirubin ≤ 3 x ULN, AST ≤ 5 x ULN, ALT ≤ 5 x ULN), Creatinine ≤ 1.5 x ULN or Ccr ≥ 50 ml/min\n* no episodes of nausea and vomiting during last 24 hours before enrollment\n* subjects provides written informed consent\n\nExclusion criteria:\n\n* subjects with uncontrolled neuro-psychiatric disease (alcohol abuse, seizure, psychosis etc) except malignant tumor\n* subject is scheduled to receive highly emetogenic chemotherapeutic agents: Doxorubicin or Epirubicin + cyclophosphamide, Cisplatin ≥ 50 mg/m2, Carmustine \\> 250 mg/m2, Cisplatin ≥ 50 mg/m2, Cyclophosphamide \\> 1,500 mg/m2, Dacarbazine, Doxurubicine ≥ 60 mg/m2, Epirubicine \\> 90 mg/m2, Ifosfamide ≥ 2 g/m2 per dose, Mechlorethamine, Streptozocin\n* contraindication to the administration of palonosetron, dexamethasone, and olanzapine due to hypersensitivity or any other reasons\n* subject has severe cognitive impairment\n* subjects has symptomatic or uncontrolled brain metastasis or brain tumor\n* female subjects of childbearing potential who dose not agree to use a proper contraceptive methods or to limit breast feeding\n* subject has taken the following agents: risperidone, quetiapine, clozapine, phenothiazine, butyrophenone, 5-HT3 antagonist, bezamides, domperidone, cannabinoids, NK1 antagonist, bezodiazepines\n* subject has a plan to receive other chemotherapy, abdomial radiation, surgery, or immunotherapy\n* any history of arrhythmia, uncontrolled congestive heart failure, acute myocardial infarction durting last 6 months\n* history of uncontrolled diabetes\n* subject who has used any investigational drugs within 30 days of randomization'}, 'identificationModule': {'nctId': 'NCT02400866', 'briefTitle': 'A Randomized Study of Olanzapine for the Prevention of CINV in Patients Receiving Moderately Emetogenic Chemotherapy', 'organization': {'class': 'NETWORK', 'fullName': 'Korean South West Oncology Group'}, 'orgStudyIdInfo': {'id': 'KSWOG 15-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'palonosetron + dexamethasone + placebo'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'palonosetron + dexamethasone + olanzapine', 'interventionNames': ['Drug: Olanzapine']}], 'interventions': [{'name': 'Olanzapine', 'type': 'DRUG', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jooyoung Lee', 'role': 'CONTACT', 'email': 'poppoya99@naver.com', 'phone': '82-42-280-7399'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korean South West Oncology Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hwan Jung Yun', 'investigatorAffiliation': 'Korean South West Oncology Group'}}}}