Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-01-22 @ 9:28 AM
Study NCT ID:
NCT03340506
Status:
RECRUITING
Last Update Posted:
2025-11-10
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dabrafenib and/or Trametinib Rollover Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561627', 'term': 'dabrafenib'}, {'id': 'C560077', 'term': 'trametinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination', 'timeFrame': "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.", 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Clinical Benefit Assessment by investigator', 'timeFrame': "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.", 'description': 'To evaluate clinical benefit as assessed by the Investigator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tafinlar', 'Mekinist', 'Dabrafenib', 'Trametinib', 'Adult', 'Melanoma', 'Melanoma Stage IV', 'Metastatic Melanoma', 'Advanced Melanoma', 'Lung Cancer', 'NSLC', 'Non Small Cell Lung Cancer', 'BRAF V600 Mutation', 'BRAF Gene Mutation', 'Solid tumor', 'Rare cancers', 'High Grade Glioma'], 'conditions': ['Melanoma', 'Non Small Cell Lung Cancer', 'Solid Tumor', 'Rare Cancers', 'High Grade Glioma']}, 'descriptionModule': {'briefSummary': 'This study is to provide access for patients who are receiving treatment with dabrafenib and/or 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib/trametinib 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/or trametinib dosing has been interrupted in the parent study."}, 'identificationModule': {'nctId': 'NCT03340506', 'briefTitle': 'Dabrafenib and/or Trametinib Rollover Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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/or Trametinib Study', 'orgStudyIdInfo': {'id': 'CDRB436X2X02B'}, 'secondaryIdInfos': [{'id': '2023-509318-13-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dabrafenib monotherapy', 'description': 'Patients in this study may receive:\n\n\\- monotherapy of dabrafenib', 'interventionNames': ['Drug: dabrafenib']}, {'type': 'EXPERIMENTAL', 'label': 'trametinib monotherapy', 'description': 'Patients in this study may receive:\n\n\\- monotherapy of trametinib', 'interventionNames': ['Drug: trametinib']}, {'type': 'EXPERIMENTAL', 'label': 'Combination therapy (dabrafenib & trametinib)', 'description': 'Patients in this study may receive:\n\n\\- the combination of dabrafenib and trametinib', 'interventionNames': ['Drug: dabrafenib', 'Drug: trametinib']}], 'interventions': [{'name': 'dabrafenib', 'type': 'DRUG', 'description': 'dabrafenib is available in capsules (50mg and 75mg) taken twice a day', 'armGroupLabels': ['Combination therapy (dabrafenib & trametinib)', 'dabrafenib monotherapy']}, {'name': 'trametinib', 'type': 'DRUG', 'description': 'trametinib is available in tablets (0.5mg, 2mg dose)', 'armGroupLabels': ['Combination therapy (dabrafenib & trametinib)', 'trametinib monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lee Davis', 'role': 'CONTACT', 'email': 'ldavis@azpoh.com', 'phone': '480-323-3990'}, {'name': 'Michael Gordon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Honor Health Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Hoffmeister', 'role': 'CONTACT', 'email': 'phoffmeister@honorhealth.com'}, {'name': 'Robert Kreitman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Institute Of Health', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'James Cancer Hospital and Solove Research Institute Ohio State', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Mary Crowley Cancer Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': 'C1121ABE', 'city': 'Caba', 'state': 'Buenos Aires', 'status': 'COMPLETED', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '100036', 'city': 'Beijing', 'status': 'COMPLETED', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': 'DK-2100', 'city': 'Copenhagen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Denmark', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '69373', 'city': 'Lyon', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '44093', 'city': 'Nantes', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75970', 'city': 'Paris', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94800', 'city': 'Villejuif', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '68305', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '13353', 'city': 'Berlin', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '4032', 'city': 'Debrecen', 'state': 'Hajdu Bihar Megye', 'status': 'COMPLETED', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': 'H 1122', 'city': 'Budapest', 'status': 'COMPLETED', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '277 8577', 'city': 'Kashiwa', 'state': 'Chiba', 'status': 'COMPLETED', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '104 0045', 'city': 'Chuo Ku', 'state': 'Tokyo', 'status': 'COMPLETED', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'COMPLETED', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 CX', 'city': 'Utrecht', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'COMPLETED', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '90110', 'city': 'Songkhla', 'state': 'Hat Yai', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}], 'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '1-888-669-6682'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '+41613241111'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}