Infigratinib
- Generic Name
- Infigratinib
- Brand Names
- Truseltiq
- Drug Type
- Small Molecule
- Chemical Formula
- C26H31Cl2N7O3
- CAS Number
- 872511-34-7
- Unique Ingredient Identifier
- A4055ME1VK
- Background
Infigratinib is a pan-fibroblast growth factor receptor (FGFR) kinase inhibitor. By inhibiting the FGFR pathway, which is often aberrated in cancers such as cholangiocarcinoma, infigratinib suppresses tumour growth. Cholangiocarcinoma is the most common primary malignancy affecting the biliary tract and the second most common primary hepatic malignancy. Infitratinib is a pan-FGFR inhibitor, as it is an ATP-competitive inhibitor of all four FGFR receptor subtypes.
On May 28, 2021, the FDA granted accelerated approval to infigratinib - under the market name Truseltiq - for the treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma in adults with a fibroblast growth factor receptor 2 (FGFR2) fusion or another rearrangement as detected by an FDA-approved test. This approval follows pemigatinib, another FGFR inhibitor approved by the FDA for the same therapeutic indication.
- Indication
Infigratinib is indicated for the treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma in adults with a fibroblast growth factor receptor 2 (FGFR2) fusion or another rearrangement as detected by an FDA-approved test.
- Associated Conditions
- Unresectable, locally advanced Cholangiocarcinomas, Unresectable, metastatic Cholangiocarcinomas
Ph Ib/BGJ398/Cervix and Other Solid Tumors
- Conditions
- Cancer of CervixTumors
- Interventions
BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
- Conditions
- Advanced Gastrointestinal Stromal Tumor (GIST)
- Interventions
- First Posted Date
- 2014-10-06
- Last Posted Date
- 2020-03-30
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 16
- Registration Number
- NCT02257541
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States
BGJ398 for Patients With Tumors With FGFR Genetic Alterations
- First Posted Date
- 2014-06-10
- Last Posted Date
- 2019-06-18
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 84
- Registration Number
- NCT02160041
- Locations
- 🇺🇸
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology, Chattanooga, Tennessee, United States
🇺🇸Virginia Cancer Specialists Fairfax Northern Virginia, Fairfax, Virginia, United States
🇺🇸Duke University Medical Center Seeley G. Mudd Bldg., Durham, North Carolina, United States
LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
- Conditions
- Melanoma
- Interventions
- First Posted Date
- 2014-06-09
- Last Posted Date
- 2024-03-05
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 158
- Registration Number
- NCT02159066
- Locations
- 🇺🇸
Doris Stein Research Center Building, Los Angeles, California, United States
🇺🇸OHSU Center for Health and Healing 2, Portland, Oregon, United States
🇺🇸University of California Los Angeles, Los Angeles, California, United States
A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
- First Posted Date
- 2013-11-05
- Last Posted Date
- 2019-12-04
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 26
- Registration Number
- NCT01975701
- Locations
- 🇺🇸
University of California San Francisco Dept of Onc., San Francisco, California, United States
🇨🇭Novartis Investigative Site, Zürich, Switzerland
🇳🇱University Medical Center Utrecht, Utrecht, The Netherlands, Netherlands
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
- Conditions
- Advanced Solid TumorsMetastatic Solid Tumors
- Interventions
- First Posted Date
- 2013-08-26
- Last Posted Date
- 2020-12-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 62
- Registration Number
- NCT01928459
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center & Research Institute Moffitt 4, Tampa, Florida, United States
🇺🇸University of Michigan Comprehensive Cancer Center SC, Ann Arbor, Michigan, United States
🇺🇸Karmanos Cancer Institute Dept of Onc, Detroit, Michigan, United States
A Phase I Study of Oral BGJ398 in Asian Patients
- First Posted Date
- 2012-10-02
- Last Posted Date
- 2020-12-08
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 9
- Registration Number
- NCT01697605
- Locations
- 🇯🇵
Nagoya University Hospital, Nagoya-city, Aichi, Japan
🇯🇵National Cancer Center Hospital East (NCEE), Kashiwa, Chiba, Japan
🇯🇵Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
- Conditions
- Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3Squamous Lung Cancer With FGFR1 AmplificationBladder Cancer With FGFR3 Mutation or FusionAdvanced Solid Tumors With FGFR1 AmplicationAdvanced Solid Tumors With FGFR2 AmplicationAdvanced Solid Tumors With FGFR3 Mutation
- Interventions
- First Posted Date
- 2009-10-29
- Last Posted Date
- 2019-10-04
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 208
- Registration Number
- NCT01004224
- Locations
- 🇺🇸
Thomas Jefferson University Hospital Onc Dept, Philadelphia, Pennsylvania, United States
🇹🇷Novartis Investigative Site, Izmir, Turkey
🇺🇸University of Colorado Dept. of Anschutz Cancer (3), Aurora, Colorado, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.