Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT00588835
Status:
TERMINATED
Last Update Posted:
2020-11-30
First Post:
2007-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009325', 'term': 'Nausea'}], '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': 'D000077608', 'term': 'Aprepitant'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-26', 'studyFirstSubmitDate': '2007-12-24', 'studyFirstSubmitQcDate': '2008-01-08', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma concentrations of etoposide will be measured', 'timeFrame': 'just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3'}], 'secondaryOutcomes': [{'measure': 'Nausea and emetic episodes are recorded', 'timeFrame': 'Day 1,3,5 and 8 of each cycle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'nausea and vomiting post chemotherapy'], 'conditions': ['Tumor']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.', 'detailedDescription': 'Aprepitant acts initially as a moderate inhibitor of CYP3A4 followed by a short period of CYP3A4 induction. Etoposide is a substrate of CYP3A4 and may therefore be suvject to a drug interaction with aprepitant.\n\nCE can be classified as a highly emetogenic chemotherapeutic regimen and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18 and 75 years of age\n* able and willing to sign informed consent form\n* indication for treatment with CE regimen\n* subject is expected to receive at least 2 cycles of CE regimen\n* able to swallow capsules\n\nExclusion Criteria:\n\n* history of sensitivity/idiosyncrasy to aprepitant or excipients\n* condition that might interfere with drug absorption, distribution metabolism or excretion.\n* history or current abuse of drugs, alcohol or solvents\n* inability to understand the nature and extent of the trial and procedures\n* participation in a drug trial within 30 days prior to the first dose\n* febrile illness within 3 days before the first dose\n* concomitant use of agents that are known to interfere with aprepitant pharmacokinetics\n* abnormal liver or renal function'}, 'identificationModule': {'nctId': 'NCT00588835', 'acronym': 'ACE', 'briefTitle': 'Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).', 'orgStudyIdInfo': {'id': 'UMCN-AKF 07.02'}, 'secondaryIdInfos': [{'id': 'EudraCTnr 2007-003347-73'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.', 'interventionNames': ['Drug: aprepitant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'CE cycle with standard anti-emetic regimen.', 'interventionNames': ['Drug: Dexamethasone and Ondansetron during CE-treatment']}], 'interventions': [{'name': 'aprepitant', 'type': 'DRUG', 'otherNames': ['Emend'], 'description': '125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.', 'armGroupLabels': ['A']}, {'name': 'Dexamethasone and Ondansetron during CE-treatment', 'type': 'DRUG', 'otherNames': ['Decadron', 'Zofran'], 'description': 'Standard anti-emetic regimen during CE treatment', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'David M. Burger, PharmD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. D. Burger, hospital pharmacist', 'oldOrganization': 'Radboud University Nijmegen Medical Centre'}}}}