[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100170837":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":20,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":20,"enrollmentInfo":74,"targetDuration":20,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":90,"whyStopped":20,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Achieve Life Sciences","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Paclitaxel\u002Fcarboplatin with custirsen","EXPERIMENTAL","Custirsen added to standard paclitaxel\u002Fcarboplatin chemotherapy",[13],"Drug: Custirsen, paclitaxel and carboplatin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Custirsen, paclitaxel and carboplatin","Custirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg\u002Fm2 IV over 3 hours) and carboplatin (AUC 6.0 mg\u002FmL\u002Fmin IV over 30 minutes) will be administered on Day 1 of each 21 day cycle",[9],null,[22,34,43,51],{"facility":23,"status":20,"city":24,"state":25,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":20},"Teva Investigational Site 002","Detroit","Michigan","United States","US",{"type":29,"coordinates":30},"Point",[31,32],-83.04575,42.33143,{"lat":32,"lon":31},{"facility":35,"status":20,"city":36,"state":37,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":38,"geoPoint":42,"contacts":20},"Teva Investigational Site 001","Dallas","Texas",{"type":29,"coordinates":39},[40,41],-96.80667,32.78306,{"lat":41,"lon":40},{"facility":44,"status":20,"city":45,"state":37,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":46,"geoPoint":50,"contacts":20},"Teva Investigational Site 003","San Antonio",{"type":29,"coordinates":47},[48,49],-98.49363,29.42412,{"lat":49,"lon":48},{"facility":52,"status":20,"city":53,"state":54,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":55,"geoPoint":59,"contacts":20},"Teva Investigational Site 004","Tacoma","Washington",{"type":29,"coordinates":56},[57,58],-122.44429,47.25288,{"lat":58,"lon":57},{"type":61,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[63],{"name":64,"class":6},"Teva Branded Pharmaceutical Products R&D, Inc.","100170837","phase-1-a-clinical-study-in-cancer-patients-to-investigate-the-potential-impact-of-custirsen-on-the-blood-levels-of-the-chemotherapeutic-drug-paclitaxel-when-given-together-as-part-of-a-treatment-regimen-100170837",false,"NCT01497470","A Clinical Study in Cancer Patients to Investigate the Potential Impact of Custirsen, on the Blood Levels of the Chemotherapeutic Drug, Paclitaxel, When Given Together as Part of a Treatment Regimen","An Open-Label, One-Arm, One-Sequence Crossover Drug-Drug Interaction Study in Advanced Solid Tumor Subjects Subjects to Evaluate the Potential Effect of Custirsen (OGX-011) on the Pharmacokinetics of Paclitaxel","Inclusion Criteria:\n\n* Confirmed diagnosis of a solid tumor that is refractory to standard therapies and is not amenable to treatment with established curative or palliative therapies and for whom paclitaxel and carboplatin is deemed an acceptable treatment by the investigator\n* Males or females ≥18 years of age\n* Life expectancy of ≥12 weeks\n* Minimum of 1 lesion\n* ECOG performance status of 0, 1 or 2\n* Adequate bone marrow reserve\n* Adequate renal and liver function\n\nExclusion Criteria:\n\n* Brain metastases that are symptomatic or require ongoing treatment\n* Major trauma or surgery within last 2 months, acute infection within 2 weeks (14 days), or radiotherapy, chemotherapy, immunotherapy or hormonal therapy within past 4 weeks\n* Persistent grade 2 or greater toxicity related to prior therapy\n* Grade 2 or greater peripheral neuropathy\n* Recent or current use of Cyp3A4, Cyp2C8 or P-gp inhibitors\n* Recent or current use of CYP enzyme inducers","ALL","18 Years",{"count":75,"type":76},36,"ACTUAL","INTERVENTIONAL",[79],"PHASE1","The primary goal of this study is to determine if custirsen has an effect on the way the body distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study will also evaluate if custirsen influences the way the body distributes and gets rid of carboplatin (another standard administered chemotherapy) and will measure custirsen blood levels in this cancer population. Finally, the study will evaluate the safety and tolerability of adding custirsen to the standard paclitaxel\u002Fcarboplatin chemotherapy.",[82],"Cancer",[84,85,86,87,88,89],"paclitaxel","carboplatin","custirsen","drug-drug interaction","pharmacokinetics","cancer","COMPLETED","2016-10-07",{"date":93,"type":94},"2016-10-10","ESTIMATED",{"date":96,"type":20},"2012-04",{"date":98,"type":76},"2013-10",{"name":5,"class":6},4]