Gastric Cancer Clinical Trial
Official title:
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
Verified date | October 2023 |
Source | LianBio LLC |
Contact | Lei Mu |
Phone | +86-021-23081188 |
Lei.mu[@]lianbio.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Recruiting |
Enrollment | 55 |
Est. completion date | December 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Hebei University | Baoding | Hebei |
China | Beijing Cancer Center | Beijing | Beijing |
China | Jilin Cancer Hospital | Changchun | Jilin |
China | Hunan Provincial People's Hospital | Changsha | Hunan |
China | Sichuan Cancer Hospital | Chengdu | Sichuan |
China | West China Hospital of Sichuan University | Chengdu | Sichuan |
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 | The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
China | Anhui Provincial Cancer Hospital | Hefei | Anhui |
China | The Second Hospital of Anhui Medical University | Hefei | Anhui |
China | Central Hospital Affiliated to Shandong First Medical University | Jinan | Shandong |
China | Shandong Provincial Cancer Hosptial | Jinan | Shandong |
China | Yunnan Cancer Hospital | Kunming | Yunnan |
China | The Second Hospital Lanzhou University | Lanzhou | Gansu |
China | Liuzhou People's Hospital | Liuzhou | Guangxi |
China | Nanjing Drum Tower Hospital | Nanjing | Jiangsu |
China | The Affiliated Hospital of Qingdao University | Qingdao | Shandong |
China | Zhongshan Hospital Fudan University | Shanghai | Shanghai |
China | The First Hospital of China Medical University | Shenyang | Liaoning |
China | Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi |
China | Tianjin Medical University Cancer Institute&Hospital | Tianjin | Tianjin |
China | Hubei Cancer Hospital | Wuhan | Hubei |
China | Tongji Hospital, Tongji Medical College of HUST | Wuhan | Hubei |
China | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
China | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
LianBio LLC |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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. |
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