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Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations (FGFR)

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Infigratinib

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Receptors, Fibroblast Growth Factor, Gastroesophageal Junction, Solid tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cohort 1 : 1) histologically or cytologically confirmed locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. 2) failed 2nd line or above therapy with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. 3) willing to do tumor biopsy for FGFR2 gene amplification via FISH test at central lab
Cohort 2: 1) Histologically or cytologically confirmed locally advanced or metastatic solid tumors other than CHOL and UC. 2) Subjects must have failed established standard medical anti-cancer therapies for a diagnosed tumor or have been intolerant to such therapy, or no standard therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds.(3) Previous documented proof of FGFR1, FGFR2 ,or FGFR3 fusions/rearrangements and activating mutations (FISH/NGS/PCR results could be accepted) presented by local laboratory or central laboratory. [Except Cohort 1GC, or GEJ patients with FGFR2 amplification]
Measurable disease by RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria:

To be eligible for the study, subjects must not meet any of the following criteria:

History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or nonmelanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study.
Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
Any known hypersensitivity to Infigratinib or its excipients.
Subjects with symptomatic central nervous system metastasis.
History and/or current evidence of extensive tissue calcification.
Amylase or lipase >2.0 × ULN.
Abnormal calcium or phosphorus, or calcium-phosphorus product ≥55 mg2/dL2.
Current evidence of endocrine alterations of calcium/phosphate homeostasis.
Current evidence of corneal or retinal disorder/keratopathy.
Currently receiving or planning to receive treatment with agents or foods that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration during this study. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs.

Sites / Locations

Beijing Cancer Hospital ( Department of Thoracic Oncology )Recruiting
Beijing Cancer Hospital (Department of Gynecological Oncology)Recruiting
Beijing Cancer HospitalRecruiting
Fujian Medical University Union HospitalRecruiting
Fujian Cancer HospitalRecruiting
The Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
Affiliated Hospital of Hebei UniversityRecruiting
Harbin Medical University Cancer HospitalRecruiting
Hubei Cancer HospitalRecruiting
The First People's Hospital of ChangzhouRecruiting
Nanjing Drum Tower HospitalRecruiting
Liaoning Cancer Hospital & InstituteRecruiting
Zhongshan Hospital Fudan UniversityRecruiting
Shanxi Provincial Cancer HospitalRecruiting
The First Affiliated Hospital Zhejiang University School of MedicineRecruiting
Sir Run Run Shaw hospital, Zhejiang University school of MedicineRecruiting
Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) with FGFR2 amplification

Advanced Solid tumors[Exclude GC/GEJ Arm and CHOL,UC]with FGFR1-3 fusions/rearrangements/mutations

Arm Description

Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off (every 4 weeks as one treatment cycle).

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Defined as the proportion of subjects with confirmed responses of CR or PR; Tumor response status will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Secondary Outcome Measures

Duration of response (DOR)

Defined as from the first evaluation as CR or PR to the first evaluation as PD or death of any cause (percent of subjects with ≥6 months, ≥9 months, and ≥12 months DOR will be reported).

Disease Control Rate (DCR)

Defined as the proportion of subjects whose best overall response is confirmed to be CR or PR or SD (RECIST v1.1).

Best Overall Response (BOR)

Defined as best response recorded from the start of the study treatment until the disease progression/recurrence

Progression-free survival (PFS)

Defined as the time from the first date of treatment to the date of progression determined by investigator or death due to any cause.

Overall Survival (OS)

Defined as the time from the first date of treatment until date of death.

Incidence of Adverse Events

The incidence of adverse events is defined as the proportion of the patients, who have adverse event(s) since the time of main informed consent.

Incidence of Serious Adverse Events

The incidence of serious adverse events is defined as the proportion of the patients, who have serious adverse event(s) since the time of main informed consent.

Incidence of Laboratory Abnormalities

Incidence of abnormal laboratory is defined as the proportion of patients who have abnormal laboratory value since the time of main informed consent.

Maximum plasma concentration (Cmax)

To characterize the pharmacokinetic parameter Maximum plasma concentration (Cmax) of Infigratinib following oral administration of Infigratinib in patients

Area under the plasma concentration versus time curve (AUC)

To characterize the pharmacokinetic parameter Area under the plasma concentration versus time curve (AUC) of Infigratinib following oral administration of Infigratinib in patients.

Apparent total plasma clearance (CL/F)

To characterize the pharmacokinetic parameter Apparent total plasma clearance (CL/F) of Infigratinib following oral administration of Infigratinib in patients.

Terminal elimination half-life (t1/2)

To characterize the pharmacokinetic parameter Terminal elimination half-life (t1/2) of Infigratinib following oral administration of Infigratinib in patients.

Accumulation ratio (Racc)

To characterize the pharmacokinetic parameter Accumulation ratio (Racc) of Infigratinib following oral administration of Infigratinib in patients.

Full Information

NCT ID

NCT05019794

First Posted

July 28, 2021

Last Updated

June 22, 2022

Sponsor

LianBio LLC

1. Study Identification

Unique Protocol Identification Number

NCT05019794

Brief Title

Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations

Acronym

FGFR

Official Title

A Phase IIa of Infigratinib in Subjects With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma With FGFR2 Amplification or Other Advanced Solid Tumors With Other FGFR Alterations

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 13, 2020 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LianBio LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 1-3. This is a multicenter, open-label, single arm phase IIa study to evaluate the efficacy and safety of Infigratinib in subjects with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 genetic amplification or other advanced solid tumors with other FGFR genetic alternations who have failed in 2nd line or above treatment. This trial includes 2 cohorts (i.e., baskets) with above mentioned indications.

Detailed Description

The subject will go through 4 periods, including Pre-screen period, screening period, treatment period and follow up period. Pre-screening period (up to 28 days) For cohort 1, subject sign pre-screening ICF( Inform consent ), subject will do tumor biopsy or provide FFPE samples before prescreening for FGFR2-amp detection by FISH from the central laboratory. If the result is positive, subjects can go through the main screening stage, otherwise participants will be considered a prescreen failure. subjects can go through the main screening stage, otherwise participants will be considered a prescreen failure. Screening period ( All cohorts; up to 28 days): Subjects who had positive genetic result could sign main ICF for all the screening examinations and establish study baseline documents. Only the eligible participants could enter the next treatment period. Treatment period: Eligible subjects will be orally administered Infigratinib (125mg, QD) for 3 weeks on, 1-week off in each 28-day cycle until the occurrence of unacceptable toxicity, disease progression, withdrawing informed consent, death, contact lost, starting a new anticancer therapy, etc (whichever occurs first). During this period, subjects will be routinely assessed efficacy status by radiographic check at W9/W17/W25/W33 . After that, subjects will be evaluated every 12 weeks until disease progression. The safety assessment will be performed at cycle 1- 4; Follow up period: Once a treatment discontinuation happens, subjects should return to the hospital within 30 days to receive a complete safety examination. Subjects with treatment discontinuation or disease progression should directly enter the follow-up period, visit approximately every 3 months for survival status reporting until withdrawing informed consent, death, contact lost, starting a new anti-cancer therapy, etc. (whichever occurs first).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor

Keywords

Gastric Cancer, Receptors, Fibroblast Growth Factor, Gastroesophageal Junction, Solid tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) with FGFR2 amplification

Arm Type

Experimental

Arm Description

Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off (every 4 weeks as one treatment cycle).

Arm Title

Advanced Solid tumors[Exclude GC/GEJ Arm and CHOL,UC]with FGFR1-3 fusions/rearrangements/mutations

Arm Type

Experimental

Arm Description

Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off (every 4 weeks as one treatment cycle).

Intervention Type

Drug

Intervention Name(s)

Infigratinib

Other Intervention Name(s)

BGJ398

Intervention Description

Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Time Frame

Approximately 12 months after dosed

Secondary Outcome Measure Information:

Title

Duration of response (DOR)

Description

Defined as from the first evaluation as CR or PR to the first evaluation as PD or death of any cause (percent of subjects with ≥6 months, ≥9 months, and ≥12 months DOR will be reported).

Time Frame

Approximately 12 months after dosed

Title

Disease Control Rate (DCR)

Description

Defined as the proportion of subjects whose best overall response is confirmed to be CR or PR or SD (RECIST v1.1).

Time Frame

Approximately 12 months after dosed

Title

Best Overall Response (BOR)

Description

Defined as best response recorded from the start of the study treatment until the disease progression/recurrence

Time Frame

Approximately 12 months after dosed

Title

Progression-free survival (PFS)

Description

Defined as the time from the first date of treatment to the date of progression determined by investigator or death due to any cause.

Time Frame

Approximately 12 months after dosed

Title

Overall Survival (OS)

Description

Defined as the time from the first date of treatment until date of death.

Time Frame

Approximately 24 months after dosed

Title

Incidence of Adverse Events

Description

The incidence of adverse events is defined as the proportion of the patients, who have adverse event(s) since the time of main informed consent.

Time Frame

Approximately 24 months

Title

Incidence of Serious Adverse Events

Description

The incidence of serious adverse events is defined as the proportion of the patients, who have serious adverse event(s) since the time of main informed consent.

Time Frame

Approximately 24 months

Title

Incidence of Laboratory Abnormalities

Description

Incidence of abnormal laboratory is defined as the proportion of patients who have abnormal laboratory value since the time of main informed consent.

Time Frame

Approximately 24 months

Title

Maximum plasma concentration (Cmax)

Description

To characterize the pharmacokinetic parameter Maximum plasma concentration (Cmax) of Infigratinib following oral administration of Infigratinib in patients

Time Frame

Approximately 5 months.

Title

Area under the plasma concentration versus time curve (AUC)

Description

To characterize the pharmacokinetic parameter Area under the plasma concentration versus time curve (AUC) of Infigratinib following oral administration of Infigratinib in patients.

Time Frame

Approximately 5 months.

Title

Apparent total plasma clearance (CL/F)

Description

To characterize the pharmacokinetic parameter Apparent total plasma clearance (CL/F) of Infigratinib following oral administration of Infigratinib in patients.

Time Frame

Approximately 5 months.

Title

Terminal elimination half-life (t1/2)

Description

To characterize the pharmacokinetic parameter Terminal elimination half-life (t1/2) of Infigratinib following oral administration of Infigratinib in patients.

Time Frame

Approximately 5 months.

Title

Accumulation ratio (Racc)

Description

To characterize the pharmacokinetic parameter Accumulation ratio (Racc) of Infigratinib following oral administration of Infigratinib in patients.

Time Frame

Approximately 5 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cohort 1 : 1) histologically or cytologically confirmed locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. 2) failed 2nd line or above therapy with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. 3) willing to do tumor biopsy for FGFR2 gene amplification via FISH test at central lab Cohort 2: 1) Histologically or cytologically confirmed locally advanced or metastatic solid tumors other than CHOL and UC. 2) Subjects must have failed established standard medical anti-cancer therapies for a diagnosed tumor or have been intolerant to such therapy, or no standard therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds.(3) Previous documented proof of FGFR1, FGFR2 ,or FGFR3 fusions/rearrangements and activating mutations (FISH/NGS/PCR results could be accepted) presented by local laboratory or central laboratory. [Except Cohort 1GC, or GEJ patients with FGFR2 amplification] Measurable disease by RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Exclusion Criteria: To be eligible for the study, subjects must not meet any of the following criteria: History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or nonmelanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study. Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor. Any known hypersensitivity to Infigratinib or its excipients. Subjects with symptomatic central nervous system metastasis. History and/or current evidence of extensive tissue calcification. Amylase or lipase >2.0 × ULN. Abnormal calcium or phosphorus, or calcium-phosphorus product ≥55 mg2/dL2. Current evidence of endocrine alterations of calcium/phosphate homeostasis. Current evidence of corneal or retinal disorder/keratopathy. Currently receiving or planning to receive treatment with agents or foods that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration during this study. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lei Mu, Master

Phone

86 21 61329798

Lei.mu@lianbio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiao Sun, Doctor

Organizational Affiliation

Shanghai LianBio Development Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Cancer Hospital ( Department of Thoracic Oncology )

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhao, Postdoctor

Phone

86 10 88196456

ohjerry@163.com

Facility Name

Beijing Cancer Hospital (Department of Gynecological Oncology)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunong Gao, Master

Phone

86 10 88196448

gao_fuke@126.com

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lin Shen

Phone

86 10 88196340

doctorshenlin@sina.cn

Facility Name

Fujian Medical University Union Hospital

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chunmei Shi, Master

Phone

86 591 86218442

scmfz@qq.com

Facility Name

Fujian Cancer Hospital

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350014

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianwei Yang, Bachelor

Phone

86 591 83660063

swzcq62@163.com

Facility Name

The Sixth Affiliated Hospital, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanhong Deng

Phone

86 20 38254084

13925106525@163.com

Facility Name

Affiliated Hospital of Hebei University

City

Baoding

State/Province

Hebei

ZIP/Postal Code

071030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aimin Zang, Master

Phone

86 312 5983056

booszam@sina.com

Facility Name

Harbin Medical University Cancer Hospital

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150081

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanqiao Zhang, Postdoctor

Phone

86 451 86298220

yanqiaozhanggcp@163.com

Facility Name

Hubei Cancer Hospital

City

Wuan

State/Province

Hubei

ZIP/Postal Code

430079

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huiting Xu, Doctor

Phone

86 27 87671530

2891533@qq.com

Facility Name

The First People's Hospital of Changzhou

City

Changzhou

State/Province

Jiangsu

ZIP/Postal Code

213004

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haijiao Yan, Doctor

Phone

86 519 68871192

haijiao8237@163.com

Facility Name

Nanjing Drum Tower Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jia Wei, Doctor

Phone

86 25 83106666

weijia_224@163.com

Facility Name

Liaoning Cancer Hospital & Institute

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110042

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jingdong Zhang, Postdoctor

Phone

86 24 31916392

13804027878@163.com

Facility Name

Zhongshan Hospital Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tianshu Liu, Doctor

Phone

86 21 64041990

liu.tianshu@zs-hospital.sh.cn

Facility Name

Shanxi Provincial Cancer Hospital

City

Taiyuan

State/Province

Shanxi

ZIP/Postal Code

030013

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yusheng Wang, Doctor

Phone

86 351 4651509

wangyusheng1972@163.com

Facility Name

The First Affiliated Hospital Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haiping Jiang, Doctor

Phone

86 571 87235657

jianghaiping75@163.com

Facility Name

Sir Run Run Shaw hospital, Zhejiang University school of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310016

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongming Pan, Doctor

Phone

86 571 86006922

shonco@sina.cn

Facility Name

Henan Cancer Hospital

City

Henan

State/Province

Zhengzhou

ZIP/Postal Code

450008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ning Li, Doctor

Phone

86 371 56155233

lining97@126.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28327938

Citation

Hierro C, Alsina M, Sanchez M, Serra V, Rodon J, Tabernero J. Targeting the fibroblast growth factor receptor 2 in gastric cancer: promise or pitfall? Ann Oncol. 2017 Jun 1;28(6):1207-1216. doi: 10.1093/annonc/mdx081. Erratum In: Ann Oncol. 2018 Jul 1;29(7):1605.

Results Reference

background

PubMed Identifier

30066580

Citation

Xue WJ, Li MT, Chen L, Sun LP, Li YY. Recent developments and advances of FGFR as a potential target in cancer. Future Med Chem. 2018 Sep 1;10(17):2109-2126. doi: 10.4155/fmc-2018-0103. Epub 2018 Aug 1.

Results Reference

background

PubMed Identifier

24265351

Citation

Dienstmann R, Rodon J, Prat A, Perez-Garcia J, Adamo B, Felip E, Cortes J, Iafrate AJ, Nuciforo P, Tabernero J. Genomic aberrations in the FGFR pathway: opportunities for targeted therapies in solid tumors. Ann Oncol. 2014 Mar;25(3):552-563. doi: 10.1093/annonc/mdt419. Epub 2013 Nov 20.

Results Reference

background

PubMed Identifier

24457912

Citation

Su X, Zhan P, Gavine PR, Morgan S, Womack C, Ni X, Shen D, Bang YJ, Im SA, Ho Kim W, Jung EJ, Grabsch HI, Kilgour E. FGFR2 amplification has prognostic significance in gastric cancer: results from a large international multicentre study. Br J Cancer. 2014 Feb 18;110(4):967-75. doi: 10.1038/bjc.2013.802. Epub 2014 Jan 23.

Results Reference

background

PubMed Identifier

31242658

Citation

Zhang J, Tang PMK, Zhou Y, Cheng ASL, Yu J, Kang W, To KF. Targeting the Oncogenic FGF-FGFR Axis in Gastric Carcinogenesis. Cells. 2019 Jun 25;8(6):637. doi: 10.3390/cells8060637.

Results Reference

background

PubMed Identifier

27870574

Citation

Nogova L, Sequist LV, Perez Garcia JM, Andre F, Delord JP, Hidalgo M, Schellens JH, Cassier PA, Camidge DR, Schuler M, Vaishampayan U, Burris H, Tian GG, Campone M, Wainberg ZA, Lim WT, LoRusso P, Shapiro GI, Parker K, Chen X, Choudhury S, Ringeisen F, Graus-Porta D, Porter D, Isaacs R, Buettner R, Wolf J. Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study. J Clin Oncol. 2017 Jan 10;35(2):157-165. doi: 10.1200/JCO.2016.67.2048. Epub 2016 Nov 21. Erratum In: J Clin Oncol. 2017 Mar 10;35(8):926. J Clin Oncol. 2019 Feb 1;37(4):358.

Results Reference

background

Links:

URL

http://pubmed.ncbi.nlm.nih.gov/28327938/

Description

To describe the FGFR2 plays a key role in gastric cancer pathogenesis. FGFR inhibitors have been tested in FGFR-aberrant GC patients. Efforts should be done to identify reliant predictive biomarkers for selecting patients most likely to benefit.

URL

http://pubmed.ncbi.nlm.nih.gov/30066580/

Description

To describe the basic knowledge regarding FGF/FGFR signaling and categorize the clinical FGFR inhibitors. The mechanisms of resistance to FGFR inhibitors and corresponding strategies of overcoming drug resistance will also be discussed.

URL

http://pubmed.ncbi.nlm.nih.gov/24265351/

Description

Strengthening the role of FGFR signaling in cancer biology and providing more possibilities for the therapeutic application of FGFR inhibitors

URL

http://pubmed.ncbi.nlm.nih.gov/31242658/

Description

A similar incidence of FGFR2 amplification was found in Asian and UK GCs and was associated with lymphatic invasion and poor prognosis.

URL

http://pubmed.ncbi.nlm.nih.gov/31242658/

Description

The pathogenic mechanisms of FGF-FGFR signaling in gastric adenocarcinoma together with the current targeted strategies in aberrant FGF-FGFR activated GC cases.

URL

http://pubmed.ncbi.nlm.nih.gov/27870574/

Description

Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I Stu

Learn more about this trial

Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations

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