Study Stopped
Business Reason
Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
A Phase II, Multicenter, Open-Label, Single Arm Study of Oral Infigratinib Monotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Who Harboring FGFR2 Gene Amplification
1 other identifier
interventional
6
1 country
30
Brief Summary
This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 gastric-cancer
Started Oct 2023
Shorter than P25 for phase_2 gastric-cancer
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2023
CompletedFirst Submitted
Initial submission to the registry
November 29, 2023
CompletedFirst Posted
Study publicly available on registry
January 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedAugust 14, 2024
August 1, 2024
8 months
November 29, 2023
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Objective response rate (ORR)
ORR: the proportion of patients with confirmed complete response (CR) or partial response (PR), assessed by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Duration of response (DoR)
DoR: the duration from the first evaluation as CR or PR to the first evaluation as progressive disease (PD) or death of any cause, per RECIST v1.1 assessed by investigator (INV) and IRC.
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Disease control rate (DCR)
DCR: the proportion of patients whose overall response is confirmed to be CR or PR or stable disease (SD) per RECIST v1.1, assessed by INV and IRC.
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Investigator evaluated ORR
the proportion of patients with confirmed CR or PR assessed by INV according to RECIST v1.1
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Progression-free survival (PFS)
the duration from the first date of treatment to the date of progression or death due to any cause, assessed by INV and IRC
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Overall survival (OS)
from the first date of Infigratinib treatment until date of death.
from the first date of Infigratinib treatment until date of death.
Study Arms (1)
Infigratinib
EXPERIMENTALInfigratinib 125 mg orally daily, 3 weeks on, 1 week off. . In patients with mild liver function abnormalities or mild renal impairment, the starting dose is 100 mg.
Interventions
Infigratinib is a selective ATP-competitive inhibitor of fibroblast growth factor receptor (FGFR) 1-3 that inhibits FGFR downstream signaling and proliferation in human cancer cell lines with FGFR genetic alterations, significantly inhibiting the growth of several types of cancers driven by FGFR amplification, fusion and mutation.
Eligibility Criteria
You may qualify if:
- years and older
- Histologically or cytologically confirmed locally advanced or metastatic gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma.
- Failed at least 2 lines of prior systemic therapy
- Willing to undergo tumor biopsy or provide FFPE samples for central lab testing.
- At least one measurable tumor lesion by RECIST v1.1
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
- Life expectancy ≥3 months.
- Willing to participate in this study and sign informed consent form, able to read and understand the study, follow the procedures.
You may not qualify if:
- History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during 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.
- History and/or current evidence of extensive tissue calcification.
- Current evidence of endocrine alterations of calcium/phosphate homeostasis.
- Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).14. Laboratory abnormality as defined in protocol.
- Considered unsuitable to participate in the study by Investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LianBio LLClead
Study Sites (30)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Beijing Cancer Center
Beijing, Beijing Municipality, 100142, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Second Hospital Lanzhou University
Lanzhou, Gansu, 730030, China
Dongguan City People's Hospital
Dongguan, Guangdong, 523059, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541199, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071030, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410002, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110002, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250013, China
Shandong Provincial Cancer Hosptial
Jinan, Shandong, 250117, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610042, China
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, 300060, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310013, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2023
First Posted
January 16, 2024
Study Start
October 19, 2023
Primary Completion
May 31, 2024
Study Completion
May 31, 2024
Last Updated
August 14, 2024
Record last verified: 2024-08