Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT01928459
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000168', 'term': 'Acrocephalosyndactylia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003398', 'term': 'Craniosynostoses'}, {'id': 'D013580', 'term': 'Synostosis'}, {'id': 'D004413', 'term': 'Dysostoses'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013576', 'term': 'Syndactyly'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568950', 'term': 'infigratinib'}, {'id': 'C585539', 'term': 'Alpelisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2013-08-21', 'studyFirstSubmitQcDate': '2013-08-21', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of dose limiting toxicities (DLTs) of the combination of BGJ398 with BYL719', 'timeFrame': 'Approximately 8 months', 'description': 'The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisioins.'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of BGJ398/BYL719 combination at the recommended dose for expansion (RDE)', 'timeFrame': 'Every 28 days from baseline visit until end of study visit', 'description': 'This will be assessed by looking at the number of Adverse Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions and reductions'}, {'measure': 'Overall response rate', 'timeFrame': 'Every two months from the date of baseline CT scan', 'description': 'Assessment of preliminary antitumor activity of the combination of BGJ398 with BYL719; Overall response rate = complete response + partial response'}, {'measure': 'Progression free survival', 'timeFrame': 'Every two months from the date of baseline CT scan', 'description': 'Assessment of preliminary antitumor activity of the combination of BGJ398 with BYL719'}, {'measure': 'Time vs. concentration profile of BGJ398 and BYL719', 'timeFrame': 'Every 28 days for up to 10 cycles', 'description': 'Plasma concentration versus time profiles. Plasma PK parameters will be used to characterize the PK profiles of the combination of BGJ398 with BYL719'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BGJ398', 'BYL719', 'advanced solid tumor', 'metastatic breast cancer', 'PK3CA', 'FGFR', 'fibroblast growth factor receptor'], 'conditions': ['Advanced Solid Tumors', 'Metastatic Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=16593', 'label': 'Results for CBGJ398X2102 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.', 'detailedDescription': 'This dose escalation/dose expansion study will evaluate the combination of orally administered BGJ398 in combination with orally administered BYL719. During the dose escalation part, the MTD of the combination will be determined in patients whose advanced or metastatic tumors express mutations to PIK3CA. Once the MTD has been determined, the expansion part will begin. Patients will be addd to one of three arms based on the disease type and genetic changes. Patients with metastatic colorectal cancer are not eligible for participation in the expansion part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists\n* Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)\n* Measurable disease defined by RECIST v1.1\n* ECOG performance status of ≤2\n\nExclusion Criteria:\n\n* Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)\n* Colorectal cancer (for patients enrolled to expansion part)\n* Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus\n* Use of medications that increase serum levels of phosphorus and/or calcium\n* Inorganic phosphorus outside of normal limits\n* Total and ionized serum calcium outside of normal limits'}, 'identificationModule': {'nctId': 'NCT01928459', 'briefTitle': 'Phase 1b Trial of BGJ398/BYL719 in Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CBGJ398X2102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metastatic breast cancer', 'description': 'Evaluation of safety and efficacy in patients with metastatic breast cancer whose tumors contain mutations to PIK3CA and alterations FGFR 1-3.', 'interventionNames': ['Drug: BGJ398', 'Drug: BYL719']}, {'type': 'EXPERIMENTAL', 'label': 'Solid tumor arm 1', 'description': 'Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA.', 'interventionNames': ['Drug: BGJ398', 'Drug: BYL719']}, {'type': 'EXPERIMENTAL', 'label': 'Solid tumor arm 2', 'description': 'Patients with solid tumors (except for colorectal cancer) whose tumomrs express mutations to PIK3CA and alterations to FGFR 1-3', 'interventionNames': ['Drug: BGJ398', 'Drug: BYL719']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation', 'description': 'To determine the MTD or RDE of the combination of BGJ398 with BYL719 in patients with advanced or metastastic solid tumors that express mutations to PIK3CA.', 'interventionNames': ['Drug: BGJ398', 'Drug: BYL719']}], 'interventions': [{'name': 'BGJ398', 'type': 'DRUG', 'description': 'BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.', 'armGroupLabels': ['Dose escalation', 'Metastatic breast cancer', 'Solid tumor arm 1', 'Solid tumor arm 2']}, {'name': 'BYL719', 'type': 'DRUG', 'description': 'BYL719 will be administered orally once daily on each day of the 28-day cycle.', 'armGroupLabels': ['Dose escalation', 'Metastatic breast cancer', 'Solid tumor arm 1', 'Solid tumor arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center & Research Institute Moffitt 4', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '48109-0944', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center SC', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute Dept of Onc', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine Onc Dept', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center Onc Dept', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center Dept of Onc', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy & Research Center / UT Health Science Center SC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20141', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '41100', 'city': 'Modena', 'state': 'MO', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '41013', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}