Truseltiq (infigratinib) / BridgeBio, Pfizer, Xediton Pharma 
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16 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Truseltiq (infigratinib) / BridgeBio, Pfizer, Xediton Pharma
PROOF 301, NCT03773302 / 2018-004004-19: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

Checkmark BridgeBio terminated ongoing phase 3 clinical trial for treating 1L cholangiocarcinoma as a result of withdrawal of NDA
Oct 2022 - Oct 2022: BridgeBio terminated ongoing phase 3 clinical trial for treating 1L cholangiocarcinoma as a result of withdrawal of NDA
Checkmark Fast track and orphan drug designation for the treatment of cholangiocarcinoma
Jan 2020 - Jan 2020: Fast track and orphan drug designation for the treatment of cholangiocarcinoma
Terminated
3
48
Europe, Canada, US, RoW
BGJ398, Infigratinib, Gemcitabine, Cisplatin
QED Therapeutics, Inc., Helsinn Healthcare SA
Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
03/23
03/23
PROPEL3, NCT06164951: A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents with Achondroplasia

Enrolling by invitation
3
110
Europe, Canada, US, RoW
Infigratinib 0.25 mg/kg/day, Placebo Comparator 0.25 mg/kg/day
QED Therapeutics, Inc.
Achondroplasia
12/25
04/26
NCT05019794: Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations

Checkmark NMPA cleared CTA to conduct the Phase 2a trial for metastatic gastric cancer or GE junction adenocarcinoma with FGFR2 gene amplification
Dec 2020 - Dec 2020: NMPA cleared CTA to conduct the Phase 2a trial for metastatic gastric cancer or GE junction adenocarcinoma with FGFR2 gene amplification
Recruiting
2a
80
RoW
Infigratinib, BGJ398
LianBio LLC
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor
12/22
12/23
2021-001855-15: A study to evaluate long-term Infigratinib in children with Achondroplasia Un estudio para evaluar Infigratinib a largo plazo en niños con acondroplasia

Not yet recruiting
2
280
Europe
Infigratinib, BGJ398 (also known as BBP-831), Tablet
QED Therapeutics, Inc., QED Therapeutics, Inc.
Achondroplasia in Children Acondroplasia en niños, Disproportionate short stature with rhizomelia (shortened proximal limbs). Estatura desproporcionádamente corta con rizomelia (miembros proximales acortados), Diseases [C] - Musculoskeletal Diseases [C05]
 
 
LOGIC-2, NCT02159066 / 2013-004552-38: LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma

Checkmark Clinical activity and tolerability data from LOGIC-2 trial of binimetinib, encorafenib with a third agent (LEE011, BKM120, BFJ398 or INC280) combination for BRAF melanoma at ECC 2015
Sep 2015 - Sep 2015: Clinical activity and tolerability data from LOGIC-2 trial of binimetinib, encorafenib with a third agent (LEE011, BKM120, BFJ398 or INC280) combination for BRAF melanoma at ECC 2015
Checkmark From LOGIC-2 trial for advanced BRAF V600 melanoma at ECC 2015
Sep 2015 - Sep 2015: From LOGIC-2 trial for advanced BRAF V600 melanoma at ECC 2015
Completed
2
158
Europe, Canada, US, RoW
LGX818, MEK162, LEE011, BGJ398, BKM120, INC280
Pfizer
Melanoma
01/23
01/23
PROPEL 2, NCT04265651 / 2019-002954-21: Study of Infigratinib in Children with Achondroplasia

Active, not recruiting
2
84
Europe, Canada, US, RoW
Infigratinib 0.016 mg/kg, Infigratinib 0.032 mg/kg, Infigratinib 0.064 mg/kg, Infigratinib 0.128 mg/kg, Infigratinib 0.25 mg/kg
QED Therapeutics, Inc.
Achondroplasia
10/24
12/24
NCT06206278: Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

Terminated
2
6
RoW
Infigratinib, BGJ398, BBP-831
LianBio LLC
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
05/24
05/24
NCT04233567: Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations

Checkmark Decision to withdraw NDA for Truseltiq which was approved for adult patients with unresectable locally advanced/metastatic 2L cholangiocarcinoma with FGFR2 fusion or other rearrangement
Oct 2022 - Oct 2022: Decision to withdraw NDA for Truseltiq which was approved for adult patients with unresectable locally advanced/metastatic 2L cholangiocarcinoma with FGFR2 fusion or other rearrangement
Checkmark Health Canada approved for the treatment of adults unresectable locally advanced or metastatic 2L cholangiocarcinoma
Sep 2021 - Sep 2021: Health Canada approved for the treatment of adults unresectable locally advanced or metastatic 2L cholangiocarcinoma
Checkmark Approved for previously-treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement
More
Active, not recruiting
2
17
US
Infigratinib, 3-(2,6-Dichloro-3,5-dimethoxyphenyl)-1-(6-((4-(4-ethylpiperazin-1-yl)phenyl)amino)pyrimidin-4-yl)-1-methylurea, BGJ-398, BGJ398
Sameek Roychowdhury
Advanced Malignant Solid Neoplasm, Cholangiocarcinoma, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
12/24
12/24
NCT05514912: Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial

Withdrawn
2
40
NA
Cisplatin, Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin, Gemcitabine Hydrochloride, dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832, FF10832, Gemcitabine HCI, Gemzar, LY-188011, LY188011, Infigratinib Phosphate, N'-(2,6-Dichloro-3,5-dimethoxyphenyl)-N-(6-(4-(4-ethylpiperazin-1-yl)anilino)pyrimidin-4-yl)-N-methylurea Phosphate (1:1), Truseltiq, Nab-paclitaxel, ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel
Emory University, National Cancer Institute (NCI)
Resectable Intrahepatic Cholangiocarcinoma, Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8, Stage I Intrahepatic Cholangiocarcinoma AJCC v8, Stage II Intrahepatic Cholangiocarcinoma AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8
06/27
06/27
NCT05145010: Extension Study of Infigratinib in Children with Achondroplasia (ACH)

Enrolling by invitation
2
300
Europe, Canada, US, RoW
Infigratinib
QED Therapeutics, Inc.
Achondroplasia
12/31
02/32
NEWEL, NCT05222165: Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations

Withdrawn
1b/2
51
Europe, Canada, US
Infigratinib, BGJ398
Helsinn Healthcare SA, Labcorp Drug Development Inc
Advanced Solid Tumor, CNS Tumor, Recurrent WHO Grade II Glioma
12/22
12/22
2021-005614-34: Study of Infigratinib in Subjects with Advanced Solid and CNS Tumorsor Recurrent or Progressive Low-Grade Glioma with Selected FGFR1-3 Alterations

Not yet recruiting
1/2
51
Europe
Infigratinib hard gelatin sprinkle capsules 18 mg, Infigratinib hard gelatin sprinkle capsules 25 mg, Infigratinib hard gelatin locking capsules 75 mg, BGJ398, BBP-831, Capsule, hard, TRUSELTIQ (infigratinib hard gelatin locking capsules 25 mg), TRUSELTIQ (infigratinib hard gelatin locking capsules 100 mg)
Helsinn Healthcare SA, Helsinn Healthcare SA
Advanced solid and CNS tumors with selected FGFR1-3 mutations or fusions/rearrangements, inclusive of recurrent or progressive low-grade glioma (LGG) with selected FGFR1-3 mutations or fusions/rearrangements., Advanced solid and central nervous system tumors (brain tumors) that is coming back after treatment (recurrent) or getting worse (progressive)., Diseases [C] - Nervous System Diseases [C10]
 
 
NCT04228042: Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer

Completed
1/2
15
US
Infigratinib, 3-(2,6-Dichloro-3,5-dimethoxyphenyl)-1-(6-((4-(4-ethylpiperazin-1-yl)phenyl)amino)pyrimidin-4-yl)-1-methylurea, BGJ-398, BGJ398, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, Surgical Procedure, Operation, Surgery, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Renal Pelvis and Ureter Urothelial Carcinoma
04/24
04/24
NCT04424966: Infigratinib in Recurrent High-Grade Glioma Patients

Terminated
1
7
US
Infigratinib
Nader Sanai, Ivy Brain Tumor Center, Barrow Neurological Institute, QED Therapeutics
Glioma, Glioblastoma, GBM
04/23
04/23
NCT05510427: Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification

Withdrawn
1
28
NA
Infigratinib, Atezolizumab, Bevacizumab
M.D. Anderson Cancer Center, Helsinn Healthcare SA
Cholangiocarcinoma, Liver Cancer
08/23
08/23
NCT02657486: BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder

Active, not recruiting
N/A
4
US
BGJ398
Memorial Sloan Kettering Cancer Center
Bladder Cancer, Non-Muscle-Invasive Urothelial Carcinoma
01/25
01/25

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