Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT01661335
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2012-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Aprepitant (Emend®) in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-20', 'releaseDate': '2021-03-24'}, {'resetDate': '2022-05-26', 'releaseDate': '2022-05-03'}], 'estimatedResultsFirstSubmitDate': '2021-03-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000077608', 'term': 'Aprepitant'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'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': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2012-06-18', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of aprepitant (Emend®) measured through a complete response', 'timeFrame': 'Up to 11 weeks, or until 3 weeks after the second course of the study regimen', 'description': '• Percentage of study subjects who demonstrate a complete response, defined as no episodes of emesis and no use of rescue medications during the investigational antiemetic cycles.'}, {'measure': 'Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication.', 'timeFrame': 'Up to 11 weeks, or until 3 weeks after the second course of the study regimen', 'description': '* The total episodes of emesis within 7 days of the first chemotherapy administration of each cycle.\n* The total number of administrations of rescue medications given for breakthrough nausea or vomiting.'}, {'measure': 'Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life', 'timeFrame': 'Up to 11 weeks, or until 3 weeks after the second course of the study regimen', 'description': '• A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire'}, {'measure': 'Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale', 'timeFrame': 'Up to 11 weeks, or until 3 weeks after the second course of the study regimen', 'description': '• A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.'}], 'secondaryOutcomes': [{'measure': 'Safety of aprepitant (Emend®)', 'timeFrame': 'Up to 11 weeks, or until 3 weeks after the second course of the study regimen', 'description': '* Occurrence of adverse events as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. These will be reported spontaneously or on inquiry by the investigator/study nurse, and continuously monitored throughout the trial.\n* Weekly complete blood count (CBC) for 3 weeks after each investigational antiemetic cycle.\n* Weekly complete metabolic profile (CMP) for 3 weeks after each investigational antiemetic cycle.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nausea', 'Vomiting', 'Children', 'Aprepitant', 'Emend®'], 'conditions': ['Nausea', 'Vomiting', 'Childhood Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.', 'detailedDescription': '1.1 Primary Aim To determine the efficacy of aprepitant (Emend®) in preventing and reducing chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic drug regimens for children receiving highly emetogenic chemotherapy. The working hypothesis will be that standard therapy + aprepitant is superior at preventing CINV than standard therapy + placebo.\n\n1.2 Secondary Aim To evaluate the safety and toxicity of aprepitant (Emend®) in children receiving highly emetogenic chemotherapy when compared to standard antiemetic therapy + placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nunder 20.99 years of age at enrollment\n\nScheduled to receive two identical cycles of highly emetogenic\\[1\\] chemotherapy for treatment of a primary malignancy, including:\n\nChemotherapy with any one or more of the following single agents in any combination:\n\n* Carboplatin\n* Carmustine \\>250 mg/m2\n* Cisplatin\n* Cyclophosphamide ≥1 g/m2\n* Dactinomycin\n* High dose Methotrexate ≥ 5 g/m2\n\nOr any of the following defined combinations:\n\n* Cyclophosphamide + anthracycline\n* Cyclophosphamide + etoposide\n* Cytarabine 150-200 mg/m2 + daunorubicin\n* Cytarabine 300 mg/m2 + etoposide\n* Cytarabine 300 mg/m2 + teniposide\n* Doxorubicin + ifosfamide\n* Doxorubicin + methotrexate 5 g/m2\n* Etoposide + ifosfamide\n\nExclusion Criteria:\n\n* Patients who have received aprepitant in the past.\n* Patients who demonstrate evidence of increased intracranial pressure.'}, 'identificationModule': {'nctId': 'NCT01661335', 'briefTitle': 'Efficacy of Aprepitant (Emend®) in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy', 'orgStudyIdInfo': {'id': '0413'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ondansetron, dexamethasone, aprepitant', 'description': 'Arm A: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.', 'interventionNames': ['Drug: Ondansetron, dexamethasone, aprepitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ondansetron, Dexamethasone, placebo', 'description': 'Arm B: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.', 'interventionNames': ['Drug: Ondansetron, Dexamethasone, placebo']}], 'interventions': [{'name': 'Ondansetron, dexamethasone, aprepitant', 'type': 'DRUG', 'otherNames': ['Aprepitant = Emend', 'ARM A'], 'description': 'Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.', 'armGroupLabels': ['Ondansetron, dexamethasone, aprepitant']}, {'name': 'Ondansetron, Dexamethasone, placebo', 'type': 'DRUG', 'otherNames': ['ARM B'], 'description': 'Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.', 'armGroupLabels': ['Ondansetron, Dexamethasone, placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Jimmy Everest Center for Cancer and Blood Disorders in Children', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Rene McNall-Knapp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-03-24', 'type': 'RELEASE'}, {'date': '2021-04-20', 'type': 'RESET'}, {'date': '2022-05-03', 'type': 'RELEASE'}, {'date': '2022-05-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Oklahoma'}}}}