A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
NCT ID: NCT05372120
Last Updated: 2023-01-04
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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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2021-12-15
2024-06-30
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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ICP-192
20 mg once daily
ICP-192
ICP-192 is a round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression
Interventions
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ICP-192
ICP-192 is a round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression
Eligibility Criteria
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Inclusion Criteria
2. ECOG ≤ 1.
3. Life expectancy of at least 3 months.
4. Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
5. Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
6. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.
Exclusion Criteria
2. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
3. Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.
18 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ye Guo
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital
Locations
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Anhui Provincal Cancer Hospital
Hefei, Anhui, China
Cancer Hospital.Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University cancer hospital
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Tumor Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Toji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Tumor Hospital
Changsha, Hunan, China
Nantong Cancer Hospital
Nantong, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
The first hospital of jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Shandong Provincial Institute of Cancer Prevention and Treatment
Jinan, Shandong, China
QiLu Hospital of Shandong University
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi An Jiaotong University
Xi’an, Shanxi, China
Sichuan Tumor Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Second People's Hospital of Yibin City
Yibin, Sichuan, China
Tianjin medical university cancer institute&hospital
Tianjin, Tianjin Municipality, China
Shaoyifu Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jiang Hao
Role: primary
Yifu He
Role: primary
Yan Sun
Role: primary
Shaojun Lin
Role: primary
Juntao Ran
Role: primary
Ting Wang
Role: backup
Weidong Li
Role: primary
Qingqing Cai
Role: primary
Xiaoying Xue
Role: primary
Tongsen Zheng
Role: primary
Shundong Cang
Role: primary
Xingya Li
Role: primary
Suxia Luo
Role: primary
Yanru Qin
Role: primary
Kunyu Yang
Role: primary
Hu Guangyuan
Role: primary
Liaoyang Shen
Role: primary
Zhenyang Liu
Role: primary
Cuihong Jiang
Role: primary
Lei Yang
Role: primary
Yong Mao
Role: primary
Jiujiang Cui
Role: primary
Bin Hu
Role: primary
Man Hu
Role: primary
Yufeng Cheng
Role: primary
Jianhua Shi
Role: primary
Guipei Zhu
Role: primary
Tianshu Liu
Role: primary
Ye Guo
Role: primary
Shaoqiang Zhang
Role: primary
Shichuan Zhang
Role: primary
Nianyong Chen
Role: primary
Kaijian Lei
Role: primary
Peiguo Wang
Role: primary
Hongming Pan
Role: primary
Meiyu Fang
Role: primary
Minghua Ge
Role: primary
Other Identifiers
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ICP-CL-00304
Identifier Type: -
Identifier Source: org_study_id
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