[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100266715":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":24,"centralContacts":19,"locations":27,"responsibleParty":40,"collaborators":19,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":19,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":19,"enrollmentInfo":52,"targetDuration":19,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":19,"overallStatus":61,"whyStopped":62,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All Patients","EXPERIMENTAL","Microgynon alone in Period 1 then with Nintedanib in Period 2",[13,14],"Drug: Microgynon","Drug: Nintedanib",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":19},"DRUG","Microgynon",null,[9],{"type":17,"name":22,"description":19,"armGroupLabels":23,"otherNames":19},"Nintedanib",[9],[25],{"name":5,"affiliation":5,"role":26},"STUDY_CHAIR",[28],{"facility":29,"status":19,"city":30,"state":19,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":19},"Klinikum Chemnitz gGmbH","Chemnitz","09116","Germany","DE",{"type":35,"coordinates":36},"Point",[37,38],12.92922,50.8357,{"lat":38,"lon":37},{"type":41,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100266715","phase-1-investigation-of-the-effect-of-nintedanib-on-the-pharmacokinetics-of-a-combination-of-ethinylestradiol-and-levonorgestrel-in-patients-with-non-small-cell-lung-cancer-100266715",true,"NCT02751385","Investigation of the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer","A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer","Inclusion criteria:\n\n* Female patients 18 years or older at screening\n* Female patient is postmenopausal or surgically sterilised\n* Patient with locally advanced, metastatic or locally recurrent non-small cell lung cancer with histology of adenocarcinoma\n* Nintedanib (Vargatef®) is planned to be prescribed in accordance with the marketing authorisation (SmPC)\n* Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial\n\nExclusion criteria:\n\n* Any contraindication to nintedanib (Vargatef®), ethinylestradiol or levonorgestrel (Microgynon®), as specified in the respective labels\n* Use of hormone containing contraceptives (including vaginal and intrauterine devices and including hormone replacement therapy) within 30 days prior to first administration of Microgynon®\n* Systemic use of drugs known to induce (e.g. rifampicin, St. John's Wort, carbamazepine) or to inhibit (e.g. azole antimycotics, macrolides) CYP3A4 within 7 days prior to first trial drug administration until last pharmacokinetic(PK)-sampling in the trial. Exception: allowed is the intake of corticosteroids as docetaxel (pre)medication\n* History of major thrombotic or clinically relevant major bleeding event in the past 6 months\n* Persistence of clinically relevant therapy related toxicities (i.e. \\> Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade 2) from previous chemotherapy and\u002For radiotherapy\n* Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial\n* Gastrointestinal disorders or abnormalities that would interfere with absorption of the trial drugs\n* Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first treatment within the trial and without complete wound healing\n* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial\n* Patients unable to comply with the protocol\n* Previous enrolment in this trial",false,"FEMALE","18 Years",{"count":53,"type":54},2,"ACTUAL","INTERVENTIONAL",[57],"PHASE1","Investigate the effect of multiple oral doses of nintedanib on the single dose kinetics of a combination of ethinylestradiol and levonorgestrel (Microgynon®)",[60],"Carcinoma, Non-Small-Cell Lung","TERMINATED","Terminated- Study halted due to low recruitment.","2018-11-22",{"date":65,"type":54},"2019-03-14",{"date":67,"type":54},"2016-05-20",{"date":69,"type":54},"2017-11-28",{"name":5,"class":6},1]