[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04641247":3,"trial-entities:NCT04641247":358,"trial-summary:NCT04641247":363},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":40,"secondary_outcomes":60,"sex":61,"minimum_age":62,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":75,"locations":78,"central_contacts":347,"overall_officials":352,"references":356,"see_also_links":357},"NCT04641247","213409","A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline\u002FTESARO-sponsored Niraparib Study","An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline\u002FTESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib","RECRUITING","2026-12-28","2026-06","2026-06-24","2021-04-16","GlaxoSmithKline","INDUSTRY",false,"This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline\u002FTESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.",null,[19,20],"Ovarian Neoplasms","Breast Neoplasms",[22,23,24,25,26],"Adverse events","Open-label extension","Parent study","Niraparib","Safety","INTERVENTIONAL","TREATMENT",[30],"PHASE2",{"count":32,"type":33},37,"ESTIMATED",[35],{"type":36,"name":25,"description":37,"armGroupLabels":38},"DRUG","Niraparib tablets or capsules will be given once a day via the oral route.",[39],"Participants receiving niraparib",[41,45,48,51,54,57],{"measure":42,"description":43,"timeFrame":44},"Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)","AEs, SAEs and AESI will be collected.","Up to 5 years",{"measure":46,"description":47,"timeFrame":44},"Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status","The performance status will be assessed using ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care) and Grade 4 (completely disabled). Number of participants with clinically significant changes in ECOG performance status will be summarized.",{"measure":49,"description":50,"timeFrame":44},"Number of participants with clinically significant changes in hematology and clinical chemistry parameters","Blood samples will be collected for the analysis of hematology and clinical chemistry parameters.",{"measure":52,"description":53,"timeFrame":44},"Number of participants with clinically significant changes in vital signs","Number of participants with clinically significant changes in vital signs will be assessed.",{"measure":55,"description":56,"timeFrame":44},"Number of participants with clinically significant changes in physical examination","Number of participants with clinically significant changes in physical examination will be assessed.",{"measure":58,"description":59,"timeFrame":44},"Number of participants with use of concomitant medications","Number of participants using concomitant medications will be assessed.",[],"ALL","18 Years",{"inclusion":64,"exclusion":70,"raw_text":74},[65,66,67,68,69],"Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.","Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.","Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline\u002FTESARO-sponsored study that has fulfilled the requirements for the primary objective.","Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.","Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug.",[71,72,73],"Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.","Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume.","Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).","Inclusion Criteria:\n\n* Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.\n* Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.\n* Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline\u002FTESARO-sponsored study that has fulfilled the requirements for the primary objective.\n* Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.\n* Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug.\n\nExclusion Criteria:\n\n* Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.\n* Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume.\n* Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).",[76,77],"ADULT","OLDER_ADULT",[79,89,108,119,125,132,144,156,168,180,192,204,216,223,235,246,259,271,283,290,297,303,315,327,339],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"GSK Investigational Site","COMPLETED","Tucson","Arizona","85710","United States",{"lat":87,"lon":88},32.22174,-110.92648,{"facility":80,"status":8,"city":90,"state":91,"zip":92,"country":85,"contacts":93,"geoPoint":105},"Encinitas","California","92024",[94,99,102],{"name":95,"role":96,"phone":97,"email":98},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":100,"role":96,"phone":101,"email":98},"EU GSK Clinical Trials Call Centre","+44 (0) 20 8990 4466",{"name":103,"role":104},"Alberto Bessudo","PRINCIPAL_INVESTIGATOR",{"lat":106,"lon":107},33.03699,-117.29198,{"facility":80,"status":8,"city":109,"state":91,"zip":110,"country":85,"contacts":111,"geoPoint":116},"Los Angeles","90048",[112,113,114],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":115,"role":104},"Bobbie Rimel",{"lat":117,"lon":118},34.05223,-118.24368,{"facility":80,"status":81,"city":120,"state":91,"zip":121,"country":85,"geoPoint":122},"Whittier","90603",{"lat":123,"lon":124},33.97918,-118.03284,{"facility":80,"status":81,"city":126,"state":127,"zip":128,"country":85,"geoPoint":129},"Jacksonville","Florida","32224",{"lat":130,"lon":131},30.33218,-81.65565,{"facility":80,"status":8,"city":133,"state":134,"zip":135,"country":85,"contacts":136,"geoPoint":141},"Atlanta","Georgia","30342",[137,138,139],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":140,"role":104},"Meaghan Tenney",{"lat":142,"lon":143},33.749,-84.38798,{"facility":80,"status":8,"city":145,"state":146,"zip":147,"country":85,"contacts":148,"geoPoint":153},"Harvey","Illinois","60426",[149,150,151],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":152,"role":104},"Ivy Abraham",{"lat":154,"lon":155},41.61003,-87.64671,{"facility":80,"status":8,"city":157,"state":158,"zip":159,"country":85,"contacts":160,"geoPoint":165},"Boston","Massachusetts","02115",[161,162,163],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":164,"role":104},"Heather Parsons",{"lat":166,"lon":167},42.35843,-71.05977,{"facility":80,"status":8,"city":169,"state":170,"zip":171,"country":85,"contacts":172,"geoPoint":177},"Grand Rapids","Michigan","60637-1470",[173,174,175],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":176,"role":104},"Manish Sharma",{"lat":178,"lon":179},42.96336,-85.66809,{"facility":80,"status":8,"city":181,"state":182,"zip":183,"country":85,"contacts":184,"geoPoint":189},"Morristown","New Jersey","07962-1956",[185,186,187],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":188,"role":104},"Nana Tchabo",{"lat":190,"lon":191},40.79677,-74.48154,{"facility":80,"status":8,"city":193,"state":194,"zip":195,"country":85,"contacts":196,"geoPoint":201},"Lake Success","New York","11042",[197,198,199],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":200,"role":104},"Veena John",{"lat":202,"lon":203},40.77066,-73.71763,{"facility":80,"status":8,"city":205,"state":206,"zip":207,"country":85,"contacts":208,"geoPoint":213},"Charlotte","North Carolina","28204",[209,210,211],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":212,"role":104},"Antoinette Tan",{"lat":214,"lon":215},35.22709,-80.84313,{"facility":80,"status":81,"city":217,"state":218,"zip":219,"country":85,"geoPoint":220},"Cleveland","Ohio","44195",{"lat":221,"lon":222},41.4995,-81.69541,{"facility":80,"status":8,"city":224,"zip":225,"country":226,"contacts":227,"geoPoint":232},"Graz","A-8036","Austria",[228,229,230],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":231,"role":104},"Edgar Petru",{"lat":233,"lon":234},47.06733,15.44197,{"facility":80,"status":8,"city":236,"zip":237,"country":226,"contacts":238,"geoPoint":243},"Vienna","1090",[239,240,241],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":242,"role":104},"Stephan Polterauer",{"lat":244,"lon":245},48.20849,16.37208,{"facility":80,"status":8,"city":247,"state":248,"zip":249,"country":250,"contacts":251,"geoPoint":256},"Kelowna","British Columbia","V5Z 4E6","Canada",[252,253,254],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":255,"role":104},"Anna Tinker",{"lat":257,"lon":258},49.88307,-119.48568,{"facility":80,"status":8,"city":260,"state":261,"zip":262,"country":250,"contacts":263,"geoPoint":268},"Toronto","Ontario","M5G 2M9",[264,265,266],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":267,"role":104},"Amit Oza",{"lat":269,"lon":270},43.70643,-79.39864,{"facility":80,"status":8,"city":272,"state":273,"zip":274,"country":250,"contacts":275,"geoPoint":280},"Montreal","Quebec","H4A 3J1",[276,277,278],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":279,"role":104},"Lucy Gilbert",{"lat":281,"lon":282},45.50884,-73.58781,{"facility":80,"status":81,"city":284,"zip":285,"country":286,"geoPoint":287},"Odense C","5000","Denmark",{"lat":288,"lon":289},55.40841,10.39538,{"facility":80,"status":81,"city":291,"zip":292,"country":293,"geoPoint":294},"Nantes","44202","France",{"lat":295,"lon":296},47.21725,-1.55336,{"facility":80,"status":81,"city":298,"zip":299,"country":293,"geoPoint":300},"Nice","06189",{"lat":301,"lon":302},43.70313,7.26608,{"facility":80,"status":8,"city":304,"zip":305,"country":306,"contacts":307,"geoPoint":312},"Haifa","3109601","Israel",[308,309,310],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":311,"role":104},"Amnon Amit",{"lat":313,"lon":314},32.81303,34.99928,{"facility":80,"status":8,"city":316,"zip":317,"country":318,"contacts":319,"geoPoint":324},"Cremona","26100","Italy",[320,321,322],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":323,"role":104},"Daniele Generali",{"lat":325,"lon":326},45.13325,10.02129,{"facility":80,"status":8,"city":328,"zip":329,"country":330,"contacts":331,"geoPoint":336},"Madrid","28040","Spain",[332,333,334],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":335,"role":104},"Antonio Casado",{"lat":337,"lon":338},40.4165,-3.70256,{"facility":80,"status":8,"city":328,"zip":340,"country":330,"contacts":341,"geoPoint":346},"28046",[342,343,344],{"name":95,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":98},{"name":345,"role":104},"Andres Redondo Sanchez",{"lat":337,"lon":338},[348,349],{"name":95,"role":96,"phone":97,"email":98},{"name":350,"role":96,"phone":351,"email":98},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",[353],{"name":354,"affiliation":13,"role":355},"GSK Clinical Trials","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":359,"biomarkers":362},[360,361],"Breast Neoplasm","Ovarian Neoplasm",[],{"nct_id":4,"found":364,"summary":365,"prompt_version":373},true,{"design":366,"status":367,"heading":6,"summary":368,"follow_up":366,"word_count":369,"commitments":370,"compensation":371,"drugs_mentioned":372},"Not specified.","completed","{\n   \"Long-term Niraparib Treatment for Ovarian and Breast Cancers\",\n   \"This study is for people who are already taking niraparib for ovarian or breast cancer as part of a GlaxoSmithKline\u002FTESARO-sponsored study. It's designed to let you continue receiving niraparib and help researchers understand its long-term safety. They will be looking at side effects (adverse events), changes in your overall health (ECOG performance status), and changes in your blood tests over up to 5 years. To join, you must be at least 18 years old, understand the study, and be willing to follow the study plan. The study aims to include 37 participants.\",\n  \"design\": \"This is an interventional study with a planned enrollment of 37 participants. It is an extension study, meaning it follows participants from previous studies.\",\n  \"commitments\": \"You will take niraparib tablets or capsules once a day by mouth. You will also need to attend scheduled visits and follow other study procedures for up to 5 years.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for up to 5 years to monitor adverse events, performance status, and blood test changes.\",\n}",185,"Not specified in the trial record.","Not stated in the trial record.",[25],"v2"]