Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-09 @ 5:51 AM
Study NCT ID:
NCT03831633
Status:
UNKNOWN
Last Update Posted:
2019-02-06
First Post:
2019-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595957', 'term': 'netupitant, palosentron drug combination'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 426}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-04', 'studyFirstSubmitDate': '2019-02-02', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-emetic response', 'timeFrame': '1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.', 'description': 'Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology']}, 'descriptionModule': {'briefSummary': 'This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, Age ≥ 18 years\n* Have a histological or cytological confirmed solid tumor malignancy\n* Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor\n* Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator's\n* Naïve of CT\n* ECOG performance up to 2\n* Able to read, understand and follow the study procedures\n* Patient with Health insurance\n\nExclusion Criteria:\n\n* Pregnancy and breastfeeding women;\n* Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;\n* Protected patients: majors under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision"}, 'identificationModule': {'nctId': 'NCT03831633', 'briefTitle': 'Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIFORFRANCE'}, 'officialTitle': 'A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.', 'orgStudyIdInfo': {'id': 'PRAKYFRA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AKYNZEO', 'interventionNames': ['Drug: Akynzeo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'interventionNames': ['Drug: Standard of Care']}], 'interventions': [{'name': 'Akynzeo', 'type': 'DRUG', 'description': '1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron).\n\n\\- Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4', 'armGroupLabels': ['AKYNZEO']}, {'name': 'Standard of Care', 'type': 'DRUG', 'description': '* oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3)\n* IV ondansetron 8 mg on Day 1\n* Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ZELEK', 'role': 'CONTACT'}], 'facility': 'CHU Avicenne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Stéphane OUARY', 'role': 'CONTACT', 'email': 'stephane.ouary@capionis.com', 'phone': '+33662755802', 'phoneExt': '5802'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIFORFRANCE', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}