[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03340506":3,"trial-entities:NCT03340506":303,"trial-summary:NCT03340506":309},{"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":24,"study_type":39,"primary_purpose":40,"phases":41,"enrollment_info":43,"interventions":46,"primary_outcomes":59,"secondary_outcomes":64,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":80,"locations":83,"central_contacts":291,"overall_officials":298,"references":301,"see_also_links":302},"NCT03340506","CDRB436X2X02B","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","RECRUITING","2032-12-28","2026-08","2026-08-25","2018-01-26","Novartis Pharmaceuticals","INDUSTRY",false,"This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",null,[19,20,21,22,23],"Melanoma","Non Small Cell Lung Cancer","Solid Tumor","Rare Cancers","High Grade Glioma",[25,26,27,28,29,19,30,31,32,33,34,20,35,36,37,38,23],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers","INTERVENTIONAL","TREATMENT",[42],"PHASE4",{"count":44,"type":45},100,"ESTIMATED",[47,54],{"type":48,"name":49,"description":50,"armGroupLabels":51},"DRUG","dabrafenib","dabrafenib is available in capsules (50mg and 75mg) taken twice a day",[52,53],"Combination therapy (dabrafenib & trametinib)","dabrafenib monotherapy",{"type":48,"name":55,"description":56,"armGroupLabels":57},"trametinib","trametinib is available in tablets (0.5mg, 2mg dose)",[52,58],"trametinib monotherapy",[60],{"measure":61,"description":62,"timeFrame":63},"Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination","Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.","Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.",[65],{"measure":66,"description":67,"timeFrame":63},"Clinical Benefit Assessment by investigator","To evaluate clinical benefit as assessed by the Investigator","ALL","18 Years","100 Years",{"inclusion":72,"exclusion":75,"raw_text":79},[73,74],"Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.","In the opinion of the Investigator would benefit from continued treatment.",[76,77,78],"Patient has been previously permanently discontinued from study treatment in the parent protocol.","Patient's indication is commercially available and reimbursed in the local country.","Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.",[81,82],"ADULT","OLDER_ADULT",[84,94,102,111,119,125,133,140,147,154,160,166,169,175,183,189,195,201,207,209,215,223,229,237,241,249,255,262,268,271,274,277,283],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"geoPoint":91},"Honor Health Research Institute","ACTIVE_NOT_RECRUITING","Scottsdale","Arizona","85258","United States",{"lat":92,"lon":93},33.50921,-111.89903,{"facility":95,"status":86,"city":96,"state":97,"zip":98,"country":90,"geoPoint":99},"National Institute Of Health","Bethesda","Maryland","20892",{"lat":100,"lon":101},38.98067,-77.10026,{"facility":103,"status":104,"city":105,"state":106,"zip":107,"country":90,"geoPoint":108},"James Cancer Hospital and Solove Research Institute Ohio State","COMPLETED","Columbus","Ohio","43210",{"lat":109,"lon":110},39.96118,-82.99879,{"facility":112,"status":104,"city":113,"state":114,"zip":115,"country":90,"geoPoint":116},"Mary Crowley Cancer 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Bihar Megye","4032","Hungary",{"lat":221,"lon":222},47.53167,21.62444,{"facility":120,"status":104,"city":224,"zip":225,"country":219,"geoPoint":226},"Budapest","1122",{"lat":227,"lon":228},47.49835,19.04045,{"facility":120,"status":104,"city":230,"state":231,"zip":232,"country":233,"geoPoint":234},"Kashiwa","Chiba","2778577","Japan",{"lat":235,"lon":236},35.86224,139.97732,{"facility":120,"status":104,"city":238,"state":239,"zip":240,"country":233},"Chuo Ku","Tokyo","1040045",{"facility":120,"status":104,"city":242,"state":243,"zip":244,"country":245,"geoPoint":246},"Rotterdam","South Holland","3015 GD","Netherlands",{"lat":247,"lon":248},51.9225,4.47917,{"facility":120,"status":86,"city":250,"zip":251,"country":245,"geoPoint":252},"Utrecht","3584 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Yai","90110","Thailand",{"lat":289,"lon":290},7.19882,100.5951,[292,296],{"name":13,"role":293,"phone":294,"email":295},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":13,"role":293,"phone":297,"email":295},"+41613241111",[299],{"name":13,"affiliation":13,"role":300},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":304,"biomarkers":308},[305,306,19,307],"Lung Non-Small Cell Carcinoma","Malignant Glioma","Solid Neoplasm",[],{"nct_id":4,"found":310,"summary":311,"prompt_version":321},true,{"design":312,"status":313,"heading":314,"summary":315,"follow_up":316,"word_count":317,"commitments":318,"compensation":319,"drugs_mentioned":320},"This is an interventional study with a planned enrollment of 100 participants. It is designed to provide continued access to treatment.","completed","Dabrafenib and\u002For Trametinib Rollover Study for Melanoma, Lung Cancer, and Other Solid Tumors","This study is for patients already taking dabrafenib and\u002For trametinib in a previous clinical trial. It aims to allow you to continue receiving these treatments if your doctor believes you are still benefiting. The main goal is to understand the long-term safety and how well patients tolerate dabrafenib and trametinib, either alone or in combination. This study is open to adults aged 18 to 100 with melanoma, non-small cell lung cancer, solid tumors, rare cancers, or high-grade glioma. The study will continue until the treatments become widely available or another access program is in place.","Participants will be followed for occurrences of side effects from the start of the study for up to approximately 10 years, or until the treatment becomes commercially available.",95,"Not specified in the trial record.","Not stated in the trial record.",[49,55],"v2"]