Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
Reason given: Business Reason
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, and Zhengzhou, ChinaSee the 30 sites
- Phase
- Phase 2
Where in China
- Affiliated Hospital of Hebei UniversityBaoding, ChinaNo longer taking part
- Beijing Cancer CenterBeijing, ChinaNo longer taking part
- Jilin Cancer HospitalChangchun, ChinaNo longer taking part
- Hunan Provincial People's HospitalChangsha, ChinaNo longer taking part
- Sichuan Cancer HospitalChengdu, ChinaNo longer taking part
- West China Hospital of Sichuan UniversityChengdu, ChinaNo longer taking part
- Dongguan City People's HospitalDongguan, ChinaNo longer taking part
- Guangzhou First People's HospitalGuangzhou, ChinaNo longer taking part
- The Sixth Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaNo longer taking part
- The Second Affiliated Hospital of Guilin Medical UniversityGuilin, ChinaNo longer taking part
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
- Harbin Medical University Cancer HospitalHarbin, ChinaNo longer taking part
- Anhui Provincial Cancer HospitalHefei, ChinaNo longer taking part
- The Second Hospital of Anhui Medical UniversityHefei, ChinaNo longer taking part
- Central Hospital Affiliated to Shandong First Medical UniversityJinan, ChinaNo longer taking part
- Shandong Provincial Cancer HosptialJinan, ChinaNo longer taking part
- Yunnan Cancer HospitalKunming, ChinaNo longer taking part
- The Second Hospital Lanzhou UniversityLanzhou, ChinaNo longer taking part
- Liuzhou People's HospitalLiuzhou, ChinaNo longer taking part
- Nanjing Drum Tower hospitalNanjing, ChinaNo longer taking part
- The Affiliated Hospital of Qingdao UniversityQingdao, ChinaNo longer taking part
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaNo longer taking part
- The First Hospital of China Medical UniversityShenyang, ChinaNo longer taking part
- Shanxi Provincial Cancer HospitalTaiyuan, ChinaNo longer taking part
- Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaNo longer taking part
- Hubei Cancer HospitalWuhan, ChinaNo longer taking part
- Tongji Hospital Tongji Medical College of HustWuhan, ChinaNo longer taking part
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaNo longer taking part
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaNo longer taking part
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaNo longer taking part
Trial details
- Who runs it
- LianBio LLC
- Trial code
- NCT06206278
- Record updated
- 14 August 2024
- 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.