8 completed, 6 terminated, 3 withdrawn, 1 unknown. 12 Phase 2, 8 Phase 1, 1 Not applicable, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Terminated 5, Completed 4, Withdrawn 2, Unknown 1 |
| Phase 1 | 8 | Completed 4, Withdrawn 3, Terminated 1 |
| Not applicable | 1 | Completed 1 |
| Phase 3 | 1 | Terminated 1 |
Follow BGJ398: new trials by email Literature Review of BGJ398 trials Research Report on BGJ398
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma Infigratinib - Gastric Cancer, Gastroesophageal Junction Adenocarcinoma | Phase 2 | Terminated | LianBio LLC | 6 | 2023-10-19 | 2024-08-14 |
| Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations Infigratinib - Advanced Solid Tumor, CNS Tumor | Phase 1 / Phase 2 | Withdrawn | Helsinn Healthcare SA | 2021-10-01 | 2023-02-23 | |
| Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer Infigratinib, Quality-of-Life Assessment, Questionnaire Administration - Renal Pelvis and Ureter Urothelial Carcinoma | Phase 1 / Phase 2 | Terminated | M.D. Anderson Cancer Center | 15 | 2020-07-28 | 2025-01-01 |
| Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations Infigratinib - Gastric Cancer, Gastroesophageal Junction Adenocarcinoma | Phase 2 | Unknown | LianBio LLC | 80 | 2020-05-13 | 2022-06-27 |
| Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Infigratinib - Advanced Malignant Solid Neoplasm, Cholangiocarcinoma | Phase 2 | Completed | Sameek Roychowdhury | 17 | 2020-01-16 | 2026-02-24 |
| Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations BGJ398, Gemcitabine, Cisplatin - Advanced Cholangiocarcinoma, FGFR2 Gene Mutation | Phase 3 | Terminated | QED Therapeutics, a BridgeBio company | 48 | 2019-12-27 | 2024-05-08 |
| BGJ398 for the Treatment of Tumor-Induced Osteomalacia BGJ398 - Tumor-Induced Osteomalacia, Oncogenic Osteomalacia | Phase 2 | Terminated | National Institute of Dental and Craniofacial Research (NIDCR) | 4 | 2019-02-27 | 2021-04-08 |
| BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer BGJ398 - FGFR Gene Amplification, FGFR1 Gene Amplification | Phase 2 | Terminated | University of Chicago | 1 | 2018-06-01 | 2019-04-16 |
| BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder BGJ398 - Bladder Cancer, Non-Muscle-Invasive Urothelial Carcinoma | Not applicable | Completed | Memorial Sloan Kettering Cancer Center | 4 | 2016-01-06 | 2026-09-02 |
| Ph Ib/BGJ398/Cervix and Other Solid Tumors BGJ398, Carboplatin, Paclitaxel - Cancer of Cervix, Tumors | Phase 1 | Withdrawn | The University of Texas Health Science Center at San Antonio | 2015-01-01 | 2015-02-16 | |
| BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST) BGJ398, Imatinib Mesylate - Advanced Gastrointestinal Stromal Tumor (GIST) | Phase 1 / Phase 2 | Completed | Memorial Sloan Kettering Cancer Center | 16 | 2014-10-02 | 2020-03-30 |
| BGJ398 for Patients With Tumors With FGFR Genetic Alterations BGJ398 - Solid Tumor, Hematologic Malignancies | Phase 2 | Terminated | Novartis Pharmaceuticals | 84 | 2014-07-24 | 2019-06-18 |
| LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma LGX818, MEK162, LEE011 - Melanoma | Phase 2 | Completed | Pfizer | 158 | 2014-07-23 | 2024-03-05 |
| A Phase 2 Study of BGJ398 in Patients With Recurrent GBM BGJ398 - Recurrent Glioblastoma or Other Glioma Subtypes | Phase 2 | Completed | Novartis Pharmaceuticals | 26 | 2013-12-09 | 2019-12-04 |
| Phase 1b Trial of BGJ398/BYL719 in Solid Tumors BGJ398, BYL719 - Advanced Solid Tumors, Metastatic Solid Tumors | Phase 1 | Completed | Novartis Pharmaceuticals | 62 | 2013-10-01 | 2020-12-09 |
| A Phase I Study of Oral BGJ398 in Asian Patients BGJ398 - Tumor With Alterations of the FGF-R | Phase 1 | Completed | Novartis Pharmaceuticals | 9 | 2012-10-19 | 2020-12-08 |
| A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies BGJ398 - Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3, Squamous Lung Cancer With FGFR1 Amplification | Phase 1 | Completed | Novartis Pharmaceuticals | 208 | 2009-12-11 | 2019-10-04 |
| Pan FGFR Kinase Inhibitor BGJ398 and Combination Chemotherapy in Treating Patients With Untreated Metastatic Pancreatic Cancer Fluorouracil, Irinotecan Hydrochloride, Laboratory Biomarker Analysis - Colon Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma | Phase 1 / Phase 2 | Withdrawn | Roswell Park Cancer Institute | 2016-05-20 |
Acrocephalosyndactylia (2) · Cholangiocarcinoma (2) · Stomach Neoplasms (2) · Urinary Bladder Neoplasms (2) · Breast Neoplasms (1) · Central Nervous System Neoplasms (1) · Colonic Neoplasms (1) · Glioblastoma (1) · Hematologic Neoplasms (1) · Hypophosphatemia (1) · Lung Neoplasms (1) · Melanoma (1) · Nasopharyngeal Neoplasms (1) · Neoplasm Metastasis (1) · Neoplasms (1)
Novartis Pharmaceuticals (5) · LianBio LLC (2) · Memorial Sloan Kettering Cancer Center (2) · Helsinn Healthcare SA (1) · M.D. Anderson Cancer Center (1) · National Institute of Dental and Craniofacial Research (NIDCR) (1) · Pfizer (1) · QED Therapeutics, a BridgeBio company (1) · Roswell Park Cancer Institute (1) · Sameek Roychowdhury (1) · The University of Texas Health Science Center at San Antonio (1) · University of Chicago (1)
United States (14) · Australia (5) · Germany (5) · Spain (5) · Canada (4) · China (4) · Italy (4) · Netherlands (4) · Belgium (3) · France (3) · South Korea (3) · Switzerland (3) · Singapore (2) · Taiwan (2) · Thailand (2)
Jonathan Rosenberg, MD (1) · Mehrad Adibi, MD (1) · Qiao Sun, Doctor (1) · Rachel I Gafni, M.D. (1) · Sameek Roychowdhury, M.D. (1) · Steven Weitman, MD (1) · Tanguy Seiwert (1) · Wen Wee Ma (1) · William Tap, MD (1)
PMID 30101387, PMID 32580579, PMID 34376578, PMID 38573872, PMID 41914670, PMID 42337043
2009 (1), 2018 (1), P30CA016056 (1)