Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
NCT ID: NCT06206278
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2023-10-19
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Infigratinib
Infigratinib 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.
Infigratinib
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.
Interventions
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Infigratinib
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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LianBio LLC
INDUSTRY
Responsible Party
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Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Center
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Second Hospital Lanzhou University
Lanzhou, Gansu, China
Dongguan City People's Hospital
Dongguan, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Shandong Provincial Cancer Hosptial
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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LB1001-203
Identifier Type: -
Identifier Source: org_study_id
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