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Showing 1–18 of 18 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: BGJ398 Clear all
Completed Phase 1Phase 2 Interventional Results available

BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

NCT02257541
View directory record Official record
Conditions
Advanced Gastrointestinal Stromal Tumor (GIST)
Interventions
BGJ398, Imatinib Mesylate
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2019
U.S. locations
7
States / cities
Boston, Massachusetts • Basking Ridge, New Jersey • Commack, New York + 4 more
Source: ClinicalTrials.gov public record
Updated Mar 29, 2020 · Synced Sep 4, 2026, 1:03 PM EDT
Terminated Phase 2 Interventional Results available

A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

NCT02150967
View directory record Official record
Conditions
Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
Interventions
BGJ398 (infigratinib)
Drug
Lead sponsor
QED Therapeutics, a BridgeBio company
Industry
Eligibility
18 Years and older
Enrollment
143 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2022
U.S. locations
11
States / cities
Phoenix, Arizona • Los Angeles, California • San Francisco, California + 5 more
Source: ClinicalTrials.gov public record
Updated Jul 2, 2023 · Synced Sep 4, 2026, 1:03 PM EDT
Terminated Phase 2 Interventional Results available

BGJ398 for Patients With Tumors With FGFR Genetic Alterations

NCT02160041
View directory record Official record
Conditions
Solid Tumor, Hematologic Malignancies
Interventions
BGJ398
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
56
States / cities
Birmingham, Alabama • Oceanside, California • San Francisco, California + 49 more
Source: ClinicalTrials.gov public record
Updated Jun 17, 2019 · Synced Sep 4, 2026, 1:03 PM EDT
Completed Phase 1 Interventional

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

NCT01928459
View directory record Official record
Conditions
Advanced Solid Tumors, Metastatic Solid Tumors
Interventions
BGJ398, BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
7
States / cities
Tampa, Florida • Ann Arbor, Michigan • Detroit, Michigan + 4 more
Source: ClinicalTrials.gov public record
Updated Dec 8, 2020 · Synced Sep 4, 2026, 1:03 PM EDT
Terminated Phase 3 Interventional Results available

Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

NCT03773302
View directory record Official record
Conditions
Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
Interventions
BGJ398, Gemcitabine, Cisplatin
Drug
Lead sponsor
QED Therapeutics, a BridgeBio company
Industry
Eligibility
18 Years and older
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
25
States / cities
Gilbert, Arizona • Tucson, Arizona • Little Rock, Arkansas + 17 more
Source: ClinicalTrials.gov public record
Updated May 7, 2024 · Synced Sep 4, 2026, 1:03 PM EDT
Completed Phase 2 Interventional Results available

Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations

NCT04233567
View directory record Official record
Conditions
Advanced Malignant Solid Neoplasm, Cholangiocarcinoma, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
Interventions
Infigratinib
Drug
Lead sponsor
Sameek Roychowdhury
Other
Eligibility
18 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Feb 23, 2026 · Synced Sep 4, 2026, 1:03 PM EDT
Completed Phase 2 Interventional Results available

A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

NCT01975701
View directory record Official record
Conditions
Recurrent Glioblastoma or Other Glioma Subtypes
Interventions
BGJ398
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
9
States / cities
Los Angeles, California • San Francisco, California • Chicago, Illinois + 5 more
Source: ClinicalTrials.gov public record
Updated Dec 3, 2019 · Synced Sep 4, 2026, 1:03 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer

NCT04228042
View directory record Official record
Conditions
Renal Pelvis and Ureter Urothelial Carcinoma
Interventions
Infigratinib, Quality-of-Life Assessment, Questionnaire Administration, Surgical Procedure
Drug · Other · Procedure
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Dec 31, 2024 · Synced Sep 4, 2026, 1:03 PM EDT
Terminated Phase 3 Interventional Results available

Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations

NCT04197986
View directory record Official record
Conditions
Upper Tract Urothelial Carcinomas, Urothelial Bladder Cancer
Interventions
Infigratinib, Placebo
Drug
Lead sponsor
QED Therapeutics, a BridgeBio company
Industry
Eligibility
18 Years and older
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
47
States / cities
Tucson, Arizona • Duarte, California • Loma Linda, California + 39 more
Source: ClinicalTrials.gov public record
Updated Mar 12, 2024 · Synced Sep 4, 2026, 1:03 PM EDT
Terminated Phase 1 Interventional Results available

Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

NCT04504331
View directory record Official record
Conditions
Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
Interventions
Infigratinib, Tamoxifen, Omnipaque 350, Iopamidol, Computed tomography (CT)
Drug · Diagnostic Test
Lead sponsor
Jennifer Lee Caswell-Jin
Other
Eligibility
18 Years and older
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Feb 11, 2026 · Synced Sep 4, 2026, 1:03 PM EDT
Completed Not applicable Interventional Results available

BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder

NCT02657486
View directory record Official record
Conditions
Bladder Cancer, Non-Muscle-Invasive Urothelial Carcinoma
Interventions
BGJ398
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2026
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Sep 4, 2026, 1:03 PM EDT
Withdrawn Phase 1Phase 2 Interventional

Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations

NCT05222165
View directory record Official record
Conditions
Advanced Solid Tumor, CNS Tumor, Recurrent WHO Grade II Glioma
Interventions
Infigratinib
Drug
Lead sponsor
Helsinn Healthcare SA
Industry
Eligibility
3 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
6
States / cities
Palo Alto, California • Washington D.C., District of Columbia • Miami, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Feb 22, 2023 · Synced Sep 4, 2026, 1:03 PM EDT
Terminated Phase 2 Interventional Results available

LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma

NCT01820364
View directory record Official record
Conditions
Melanoma
Interventions
LGX818
Drug
Lead sponsor
Array BioPharma
Industry
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 8, 2017 · Synced Sep 4, 2026, 1:03 PM EDT
Terminated Phase 2 Interventional Results available

BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer

NCT02706691
View directory record Official record
Conditions
FGFR Gene Amplification, FGFR1 Gene Amplification, FGFR2 Gene Amplification, FGFR2 Gene Mutation, FGFR3 Gene Mutation, Head and Neck Squamous Cell Carcinoma, Human Papillomavirus Infection, Recurrent Head and Neck Carcinoma, Recurrent Nasopharynx Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma
Interventions
BGJ398
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Apr 15, 2019 · Synced Sep 4, 2026, 1:03 PM EDT
Completed Phase 1 Interventional

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

NCT01004224
View directory record Official record
Conditions
Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3, Squamous Lung Cancer With FGFR1 Amplification, Bladder Cancer With FGFR3 Mutation or Fusion, Advanced Solid Tumors With FGFR1 Amplication, Advanced Solid Tumors With FGFR2 Amplication, Advanced Solid Tumors With FGFR3 Mutation
Interventions
BGJ398
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
208 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2018
U.S. locations
16
States / cities
Duarte, California • Los Angeles, California • Aurora, Colorado + 10 more
Source: ClinicalTrials.gov public record
Updated Oct 3, 2019 · Synced Sep 4, 2026, 1:03 PM EDT
Withdrawn Phase 1Phase 2 Interventional

Pan FGFR Kinase Inhibitor BGJ398 and Combination Chemotherapy in Treating Patients With Untreated Metastatic Pancreatic Cancer

NCT02575508
View directory record Official record
Conditions
Colon Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Rectal Adenocarcinoma, Stage III Pancreatic Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IV Pancreatic Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer
Interventions
Fluorouracil, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Oxaliplatin, pan FGFR Kinase Inhibitor BGJ398, Pharmacological Study
Drug · Other
Lead sponsor
Roswell Park Cancer Institute
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Buffalo, New York
Source: ClinicalTrials.gov public record
Updated May 19, 2016 · Synced Sep 4, 2026, 1:03 PM EDT
Completed Phase 2 Interventional Results available

LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma

NCT02159066
View directory record Official record
Conditions
Melanoma
Interventions
LGX818, MEK162, LEE011, BGJ398, BKM120, INC280
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
158 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2023
U.S. locations
17
States / cities
Los Angeles, California • New York, New York • Portland, Oregon + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 4, 2024 · Synced Sep 4, 2026, 1:03 PM EDT
Terminated Phase 2 Interventional Results available

BGJ398 for the Treatment of Tumor-Induced Osteomalacia

NCT03510455
View directory record Official record
Conditions
Tumor-Induced Osteomalacia, Oncogenic Osteomalacia
Interventions
BGJ398
Drug
Lead sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Eligibility
18 Years to 85 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 7, 2021 · Synced Sep 4, 2026, 1:03 PM EDT