About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

BGJ398

Company: National Institute of Dental and Craniofacial Research (NIDCR)
Mechanism: Mechanism not yet reported
Route: Route not yet reported
Recruiting trials: None currently listed

Efficacy results: Not yet reported

No recruiting studies currently listed

See all studies for this drug

Data source: ClinicalTrials.gov · trial data as of Nov 11, 2026

Trial details

Completed NCT NCT01004224

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Not yet reported Novartis Pharmaceuticals 208 participants Est. completion 2018-10-08 50 sites Stand-alone

Other 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
View official trial listing →
Completed NCT NCT01697605

A Phase I Study of Oral BGJ398 in Asian Patients

Not yet reported Novartis Pharmaceuticals 9 participants Est. completion 2019-02-07 8 sites Stand-alone

Other conditions: Tumor With Alterations of the FGF-R
View official trial listing →
Terminated NCT NCT01820364

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

Not yet reported Array BioPharma 15 participants Est. completion 2015-03 6 sites

Other conditions: Melanoma
View official trial listing →
Completed NCT NCT01928459

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Not yet reported Novartis Pharmaceuticals 62 participants Est. completion 2016-08 22 sites Stand-alone

Other conditions: Advanced Solid Tumors, Metastatic Solid Tumors
View official trial listing →
Completed NCT NCT01975701

A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

Not yet reported Novartis Pharmaceuticals 26 participants Est. completion 2018-10-03 17 sites Stand-alone

Other conditions: Recurrent Glioblastoma or Other Glioma Subtypes
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Terminated NCT NCT02150967

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

Not yet reported QED Therapeutics, a BridgeBio company 143 participants Est. completion 2022-02-07 37 sites Stand-alone

Other conditions: Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
View official trial listing →
Completed NCT NCT02159066

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

Not yet reported Pfizer 158 participants Est. completion 2023-01-10 32 sites Stand-alone

Other conditions: Melanoma
View official trial listing →
Terminated NCT NCT02160041

BGJ398 for Patients With Tumors With FGFR Genetic Alterations

Not yet reported Novartis Pharmaceuticals 84 participants Est. completion 2018-04-30 56 sites Stand-alone

Other conditions: Solid Tumor, Hematologic Malignancies
View official trial listing →
Completed NCT NCT02257541

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

Not yet reported, Not yet reported Memorial Sloan Kettering Cancer Center 16 participants Est. completion 2019-03-25 7 sites Stand-alone

Other conditions: Advanced Gastrointestinal Stromal Tumor (GIST)
View official trial listing →
Withdrawn NCT NCT02312804

Ph Ib/BGJ398/Cervix and Other Solid Tumors

Not yet reported The University of Texas Health Science Center at San Antonio Est. completion 2015-01 Stand-alone

Other conditions: Cancer of Cervix, Tumors
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Withdrawn NCT NCT02575508

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

Not yet reported, Not yet reported Roswell Park Cancer Institute 1 site Stand-alone

Other 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
View official trial listing →
Completed NCT NCT02657486

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

Not yet reported Memorial Sloan Kettering Cancer Center 4 participants Est. completion 2026-02-04 1 site Stand-alone

Other conditions: Bladder Cancer, Non-Muscle-Invasive Urothelial Carcinoma
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Terminated NCT NCT02706691

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

Not yet reported University of Chicago 1 participants Est. completion 2019-02-11 1 site Stand-alone

Other 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
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Terminated NCT NCT03510455

BGJ398 for the Treatment of Tumor-Induced Osteomalacia

Not yet reported National Institute of Dental and Craniofacial Research (NIDCR) 4 participants Est. completion 2020-05-04 1 site Stand-alone

Other conditions: Tumor-Induced Osteomalacia, Oncogenic Osteomalacia
View official trial listing →
Terminated NCT NCT03773302

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

Not yet reported QED Therapeutics, a BridgeBio company 48 participants Est. completion 2023-03-02 116 sites Stand-alone

Other conditions: Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
View official trial listing →
Terminated NCT NCT04197986

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

Not yet reported QED Therapeutics, a BridgeBio company 39 participants Est. completion 2023-02-28 143 sites

Other conditions: Upper Tract Urothelial Carcinomas, Urothelial Bladder Cancer
View official trial listing →
Terminated NCT NCT04228042

Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer

Not yet reported, Not yet reported M.D. Anderson Cancer Center 15 participants Est. completion 2024-04-17 1 site

Other conditions: Renal Pelvis and Ureter Urothelial Carcinoma
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Completed NCT NCT04233567

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

Not yet reported Sameek Roychowdhury 17 participants Est. completion 2024-12-12 1 site

Other conditions: Advanced Malignant Solid Neoplasm, Cholangiocarcinoma, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
View official trial listing →
Terminated NCT NCT04504331

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

Not yet reported Jennifer Lee Caswell-Jin 4 participants Est. completion 2021-10-22 1 site

Other conditions: Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
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Withdrawn NCT NCT04972253

Phase I BLASST-3 Trial

Not yet reported Guru P. Sonpavde Est. completion 2023-12

Other conditions: Bladder Transitional Cell Carcinoma, Bladder Cancer, Fibroblast Growth Factor Receptor
View official trial listing →
Status unknown NCT NCT05019794

Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations

Not yet reported LianBio LLC 80 participants Est. completion 2023-12-30 17 sites Stand-alone

Other conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor
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Withdrawn NCT NCT05222165

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

Not yet reported, Not yet reported Helsinn Healthcare SA Est. completion 2022-12-16 10 sites Stand-alone

Other conditions: Advanced Solid Tumor, CNS Tumor, Recurrent WHO Grade II Glioma
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Terminated NCT NCT06206278

Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

Not yet reported LianBio LLC 6 participants Est. completion 2024-05-31 30 sites

Other conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
View official trial listing →

Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

ClinicalTrials.gov — NCT03510455

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This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.