Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
- Conditions
- Gastroesophageal Junction AdenocarcinomaGastric Cancer
- Interventions
- Registration Number
- NCT06206278
- Lead Sponsor
- LianBio LLC
- 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Infigratinib 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.
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Week9/17/25/33 and every 12 weeks after (up to 2 years) 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.
Duration of response (DoR) Week9/17/25/33 and every 12 weeks after (up to 2 years) 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.
Disease control rate (DCR) Week9/17/25/33 and every 12 weeks after (up to 2 years) 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.
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.
Investigator evaluated ORR Week9/17/25/33 and every 12 weeks after (up to 2 years) the proportion of patients with confirmed CR or PR assessed by INV according to RECIST v1.1
Progression-free survival (PFS) Week9/17/25/33 and every 12 weeks after (up to 2 years) the duration from the first date of treatment to the date of progression or death due to any cause, assessed by INV and IRC
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Anhui Provincial Cancer Hospital
🇨🇳Hefei, Anhui, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Hospital Lanzhou University
🇨🇳Lanzhou, Gansu, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi, China
The Second Affiliated Hospital of Guilin Medical University
🇨🇳Guilin, Guangxi, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Dongguan City People's Hospital
🇨🇳Dongguan, Guangdong, China
Beijing Cancer Center
🇨🇳Beijing, Beijing, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
The Sixth Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Tongji Hospital, Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, 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, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, 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, China