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Leállítva2. fázis

Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

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Key facts

Where
Baoding, Beijing, Changchun, Changsha, Chengdu, Dongguan, Guangzhou, Guilin, Hangzhou, Harbin, Hefei, Jinan, Kunming, Lanzhou, Liuzhou, Nanjing, Qingdao, Shanghai, Shenyang, Taiyuan, Tianjin, Wuhan, Xi’an, Xiamen és Zhengzhou, KínaSee the 30 sites
Phase
2. fázis

Where in Kína

  • Affiliated Hospital of Hebei UniversityBaoding, KínaNo longer taking part
  • Beijing Cancer CenterBeijing, KínaNo longer taking part
  • Jilin Cancer HospitalChangchun, KínaNo longer taking part
  • Hunan Provincial People's HospitalChangsha, KínaNo longer taking part
  • Sichuan Cancer HospitalChengdu, KínaNo longer taking part
  • West China Hospital of Sichuan UniversityChengdu, KínaNo longer taking part
  • Dongguan City People's HospitalDongguan, KínaNo longer taking part
  • Guangzhou First People's HospitalGuangzhou, KínaNo longer taking part
  • The Sixth Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, KínaNo longer taking part
  • The Second Affiliated Hospital of Guilin Medical UniversityGuilin, KínaNo longer taking part
  • The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, KínaNo longer taking part
  • Harbin Medical University Cancer HospitalHarbin, KínaNo longer taking part
  • Anhui Provincial Cancer HospitalHefei, KínaNo longer taking part
  • The Second Hospital of Anhui Medical UniversityHefei, KínaNo longer taking part
  • Central Hospital Affiliated to Shandong First Medical UniversityJinan, KínaNo longer taking part
  • Shandong Provincial Cancer HosptialJinan, KínaNo longer taking part
  • Yunnan Cancer HospitalKunming, KínaNo longer taking part
  • The Second Hospital Lanzhou UniversityLanzhou, KínaNo longer taking part
  • Liuzhou People's HospitalLiuzhou, KínaNo longer taking part
  • Nanjing Drum Tower hospitalNanjing, KínaNo longer taking part
  • The Affiliated Hospital of Qingdao UniversityQingdao, KínaNo longer taking part
  • Zhongshan Hospital,Fudan UniversityShanghai, KínaNo longer taking part
  • The First Hospital of China Medical UniversityShenyang, KínaNo longer taking part
  • Shanxi Provincial Cancer HospitalTaiyuan, KínaNo longer taking part
  • Tianjin Medical University Cancer Institute & HospitalTianjin, KínaNo longer taking part
  • Hubei Cancer HospitalWuhan, KínaNo longer taking part
  • Tongji Hospital Tongji Medical College of HustWuhan, KínaNo longer taking part
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, KínaNo longer taking part
  • The First Affiliated hospital of Xiamen UniversityXiamen, KínaNo longer taking part
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, KínaNo longer taking part

Trial details

Who runs it
LianBio LLC
Trial code
NCT06206278
Record updated
2024. augusztus 14.
Original description
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 .Read full original descriptionShow less

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

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 .

Inclusion: 18 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.

Exclusion: Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor; 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; Any known hypersensitivity to infigratinib or its excipients; 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; History and/or current evidence of extensive tissue calcification; Considered unsuitable to participate in the study by Investigator.

ClinicalTrials.gov NCT06206278