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BGJ398

DRUG12 trials

Sponsors

Novartis Pharmaceuticals, Pfizer, Memorial Sloan Kettering Cancer Center, The University of Texas Health Science Center at San Antonio, University of Chicago

Conditions

Advanced CholangiocarcinomaAdvanced Gastrointestinal Stromal Tumor (GIST)Advanced Solid TumorsAdvanced Solid Tumors With Alterations of FGFR1, 2 and or 3Advanced Solid Tumors With FGFR1 AmplicationAdvanced Solid Tumors With FGFR2 AmplicationAdvanced Solid Tumors With FGFR3 MutationBladder Cancer

Phase 1

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
CompletedNCT01004224
Novartis PharmaceuticalsAdvanced Solid Tumors With Alterations of FGFR1, 2 and or 3, Advanced Solid Tumors With FGFR1 Amplication, Advanced Solid Tumors With FGFR2 Amplication +3
Start: 2009-12-11End: 2018-10-08Updated: 2019-10-04
A Phase I Study of Oral BGJ398 in Asian Patients
CompletedNCT01697605
Novartis PharmaceuticalsTumor With Alterations of the FGF-R
Start: 2012-10-19End: 2019-02-07Updated: 2020-12-08
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
CompletedNCT01928459
Novartis PharmaceuticalsAdvanced Solid Tumors, Metastatic Solid Tumors
Start: 2013-10-31End: 2016-08-31Updated: 2020-12-09
BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
CompletedNCT02257541
Memorial Sloan Kettering Cancer CenterAdvanced Gastrointestinal Stromal Tumor (GIST)
Start: 2014-10-02End: 2019-03-25Updated: 2020-03-30
Ph Ib/BGJ398/Cervix and Other Solid Tumors
WithdrawnNCT02312804
The University of Texas Health Science Center at San AntonioCancer of Cervix, Tumors
Start: 2015-01-31End: 2015-01-31Updated: 2015-02-16

Phase 2

A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
CompletedNCT01975701
Novartis PharmaceuticalsRecurrent Glioblastoma or Other Glioma Subtypes
Start: 2013-12-09End: 2018-10-03Updated: 2019-12-04
LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
CompletedNCT02159066
PfizerMelanoma
Start: 2014-07-23End: 2023-01-10Updated: 2024-03-05
BGJ398 for Patients With Tumors With FGFR Genetic Alterations
TerminatedNCT02160041
Novartis PharmaceuticalsHematologic Malignancies, Solid Tumor
Start: 2014-07-24End: 2018-04-30Updated: 2019-06-18
BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer
TerminatedNCT02706691
University of ChicagoFGFR1 Gene Amplification, FGFR2 Gene Amplification, FGFR2 Gene Mutation +7
Start: 2018-06-01End: 2019-02-11Updated: 2019-04-16
BGJ398 for the Treatment of Tumor-Induced Osteomalacia
TerminatedNCT03510455
National Institute of Dental and Craniofacial Research (NIDCR)Oncogenic Osteomalacia, Tumor-Induced Osteomalacia
Start: 2019-02-27End: 2020-05-04Updated: 2021-04-08

Phase 3

Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
TerminatedNCT03773302
QED Therapeutics, a BridgeBio companyAdvanced Cholangiocarcinoma, FGFR2 Gene Mutation
Start: 2019-12-27End: 2023-03-02Updated: 2024-05-08

Unknown Phase

BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
CompletedNCT02657486
Memorial Sloan Kettering Cancer CenterBladder Cancer, Non-Muscle-Invasive Urothelial Carcinoma
Start: 2016-01-06End: 2026-02-04Updated: 2026-09-02

Related Papers

Longitudinal Genomic Analysis to Fine-tune Targeted Therapy: Results of the Phase II LOGIC 2 Trial in Patients with <i>BRAF</i> V600-Mutant Metastatic Melanoma
Clinical Cancer Research2025-03-192 citations
PROOF 301: Results of an early discontinued randomized phase 3 trial of the oral FGFR inhibitor infigratinib vs. gemcitabine plus cisplatin in patients with advanced cholangiocarcinoma (CCA) with an <i>FGFR2</i> gene fusion/rearrangement.
Journal of Clinical Oncology2024-01-2013 citations
The future of fibroblast growth factor receptor inhibitors and mechanisms of resistance for cholangiocarcinoma.
2023-04-145 citations
Multidisciplinary management in the treatment of intrahepatic cholangiocarcinoma
CA A Cancer Journal for Clinicians2023-04-128 citations
PROOF 301: A multicenter, open-label, randomized, phase 3 trial of infigratinib versus gemcitabine plus cisplatin in patients with advanced cholangiocarcinoma with an <i>FGFR2</i> gene fusion/rearrangement.
Journal of Clinical Oncology2022-06-0110 citations
Final results from a phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor, in patients with previously treated advanced cholangiocarcinoma harboring an <i>FGFR2</i> gene fusion or rearrangement.
Journal of Clinical Oncology2021-01-2086 citations
FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with <i>FGFR2</i> rearrangements
Future Oncology2020-07-17158 citations
Infigratinib in patients with advanced cholangiocarcinoma with <i>FGFR2</i> gene fusions/translocations: the PROOF 301 trial
Future Oncology2020-06-2587 citations
A phase II, multicenter study of encorafenib/binimetinib followed by a rational triple-combination after progression in patients with advanced BRAF V600-mutated melanoma (LOGIC2).
Journal of Clinical Oncology2020-05-2016 citations
Infigratinib and treatment response in advanced/unresectable or metastatic urothelial carcinoma in first-line and later-line treatment settings.
Journal of Clinical Oncology2020-05-206 citations
Marker lesion study of oral FGFR inhibitor BGJ398 in patients with FGFR3-altered intermediate-risk nonmuscle-invasive bladder cancer.
Journal of Clinical Oncology2020-02-198 citations
Relationship between hyperphosphatemia with infigratinib (BGJ398) and efficacy in <i>FGFR3</i>-altered advanced/metastatic urothelial carcinoma (aUC).
Journal of Clinical Oncology2020-02-191 citations
ACTR-33. INFIGRATINIB (BGJ398) IN PATIENTS WITH RECURRENT GLIOMAS WITH FIBROBLAST GROWTH FACTOR RECEPTOR (FGFR) ALTERATIONS: A MULTICENTER PHASE II STUDY
Neuro-Oncology2019-11-017 citations
OS10.6 Infigratinib (BGJ398) in patients with recurrent gliomas with fibroblast growth factor receptor (FGFR) alterations: a multicenter phase II study
Neuro-Oncology2019-08-0111 citations
Infigratinib versus gemcitabine plus cisplatin multicenter, open-label, randomized, phase 3 study in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF trial.
Journal of Clinical Oncology2019-05-2022 citations
Infigratinib in upper tract urothelial carcinoma vs urothelial carcinoma of the bladder and association with comprehensive genomic profiling/cell-free DNA results.
Journal of Clinical Oncology2019-05-208 citations
A phase Ib study of BGJ398, a pan-FGFR kinase inhibitor in combination with imatinib in patients with advanced gastrointestinal stromal tumor.
2018-08-1333 citations
A phase Ib study of BGJ398 in combination with imatinib in patients with advanced gastrointestinal stromal tumor (GIST).
Journal of Clinical Oncology2017-05-201 citations
Fibroblast kinase 1-3 inhibitor BGJ398 in patients with <i>FGFR1</i> amplified squamous non-small cell lung cancer treated in a phase I study: Evaluation of tumor tissue and response at a single center.
Journal of Clinical Oncology2017-05-20
Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR<sup>+</sup>, HER2<sup>-</sup> breast cancer that had progressed during or after prior endocrine therapy.
2017-02-1078 citations

4 more papers not shown