Infigratinib

Generic Name: Infigratinib

Brand Names: Truseltiq

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₃₁Cl_₂N_₇O_₃

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

Clinical Trials

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

Phase 1

Terminated

Conditions: Breast Cancer
HER2-negative Breast Cancer
ER Positive Breast Cancer
PR-Positive Breast Cancer

Interventions: Drug: Infigratinib
Drug: Tamoxifen
Drug: Omnipaque 350
Drug: Iopamidol
Diagnostic Test: Computed tomography (CT)

First Posted Date: 2020-08-07

Last Posted Date: 2023-06-01

Lead Sponsor: Jennifer Lee Caswell-Jin

Target Recruit Count: 4

Registration Number: NCT04504331

Locations: 🇺🇸
Stanford University, Stanford, California, United States

Infigratinib in Recurrent High-Grade Glioma Patients

Early Phase 1

Terminated

Conditions: Glioma
GBM
Glioblastoma

Interventions: Drug: Infigratinib

First Posted Date: 2020-06-11

Last Posted Date: 2024-03-27

Lead Sponsor: Nader Sanai

Target Recruit Count: 7

Registration Number: NCT04424966

Locations: 🇺🇸
Chandler Regional Medical Center, Chandler, Arizona, United States
🇺🇸
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
🇺🇸
HonorHealth Scottsdale Osborn Medical Center, Scottsdale, Arizona, United States

Study of Infigratinib in Children with Achondroplasia

Phase 2

Completed

Conditions: Achondroplasia

Interventions: Drug: Infigratinib 0.016 mg/kg
Drug: Infigratinib 0.032 mg/kg
Drug: Infigratinib 0.128 mg/kg
Drug: Infigratinib 0.064 mg/kg
Drug: Infigratinib 0.25 mg/kg

First Posted Date: 2020-02-11

Last Posted Date: 2025-03-26

Lead Sponsor: QED Therapeutics, Inc.

Target Recruit Count: 84

Registration Number: NCT04265651

Locations: 🇺🇸
Johns Hopkins School of Medicine, Baltimore, Maryland, United States
🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇺🇸
UCSF Benioff Children's Hospital, Oakland, California, United States

and more 16 locations

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

Phase 2

Active, not recruiting

Conditions: Cholangiocarcinoma
Advanced Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm

Interventions: Drug: Infigratinib

First Posted Date: 2020-01-18

Last Posted Date: 2025-02-06

Lead Sponsor: Sameek Roychowdhury

Target Recruit Count: 17

Registration Number: NCT04233567

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer

Phase 1

Terminated

Conditions: Renal Pelvis and Ureter Urothelial Carcinoma

Interventions: Drug: Infigratinib
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Procedure: Surgical Procedure

First Posted Date: 2020-01-14

Last Posted Date: 2025-01-01

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 15

Registration Number: NCT04228042

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

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

Phase 3

Terminated

Conditions: Upper Tract Urothelial Carcinomas
Urothelial Bladder Cancer

Interventions: Drug: Infigratinib
Drug: Placebo

First Posted Date: 2019-12-13

Last Posted Date: 2024-03-13

Lead Sponsor: QED Therapeutics, Inc.

Target Recruit Count: 39

Registration Number: NCT04197986

Locations: 🇺🇸
The Ohio State University College of Medicine, Columbus, Ohio, United States
🇺🇸
Associated Medical Professionals - Syracuse, Syracuse, New York, United States
🇺🇸
New Jersey Urology - Saddle Brook, Saddle Brook, New Jersey, United States

and more 133 locations

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

Phase 3

Terminated

Conditions: Advanced Cholangiocarcinoma
FGFR2 Gene Mutation

Interventions: Drug: BGJ398
Drug: Gemcitabine
Drug: Cisplatin

First Posted Date: 2018-12-12

Last Posted Date: 2024-05-08

Lead Sponsor: QED Therapeutics, Inc.

Target Recruit Count: 48

Registration Number: NCT03773302

Locations: 🇺🇸
Parkland Health and Hospital System, Dallas, Texas, United States
🇺🇸
Northwestern Memorial Hospital, Chicago, Illinois, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 113 locations

BGJ398 for the Treatment of Tumor-Induced Osteomalacia

Phase 2

Terminated

Conditions: Oncogenic Osteomalacia
Tumor-Induced Osteomalacia

Interventions: Drug: BGJ398

First Posted Date: 2018-04-27

Last Posted Date: 2021-04-08

Lead Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Target Recruit Count: 4

Registration Number: NCT03510455

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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

Phase 2

Terminated

Conditions: FGFR1 Gene Amplification
FGFR2 Gene Amplification
FGFR2 Gene Mutation
Head and Neck Squamous Cell Carcinoma
FGFR Gene Amplification
Recurrent Nasopharynx Carcinoma
FGFR3 Gene Mutation
Human Papillomavirus Infection
Recurrent Head and Neck Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma