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This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-192 | Experimental | 20 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-192 | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). | From the time of first dose until objective disease progression, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | DOR is time interval from the first date that criteria for complete response or partial response are met to the first date of progression of disease | From the time of first dose until objective disease progression, an average of 6 months |
| Disease Control Rate (DCR) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression free survival is the time period from start of study medication till the disease progression or death, whichever occurs first. | From the time of first dose until objective disease progression, an average of 6 months |
| Overall survival (OS) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ye Guo | Contact | 13501678472 | pattrickguo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye Guo | Shanghai East Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of bengbu medical college | Recruiting | Bengbu | Anhui | 233000 | China |
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DCR based on assessment of confirmed Complete response (CR), partial response (PR) or stable disease(SD) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). |
| From the time of first dose until objective disease progression, an average of 6 months |
OS is the time period from start of study medication untill death from any cause. |
| From the time of first dose until objective disease progression, an average of 1 year |
| Anhui Provincal Cancer Hospital | Recruiting | Hefei | Anhui | 230031 | China |
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| Cancer Hospital.Chinese Academy of Medical Sciences | Active, not recruiting | Beijing | Beijing Municipality | 100021 | China |
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| The First Affiliated Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| The Second Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 50000 | China |
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| Harbin Medical University cancer hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450003 | China |
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| Henan Tumor Hospital | Not yet recruiting | Zhengzhou | Henan | 450008 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Union Hospital Toji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
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| Tongji Hospital Tongji Medical College of HUST | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Xiangya Hospital Central South University | Not yet recruiting | Changsha | Hunan | 410008 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410013 | China |
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| Hunan Tumor Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| Nantong Cancer Hospital | Recruiting | Nantong | Jiangsu | 226361 | China |
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| Affiliated Hospital of Jiangnan University | Recruiting | Wuxi | Jiangsu | 214122 | China |
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| The first hospital of jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| Liaoning Cancer Hospital & Institute | Recruiting | Shenyang | Liaoning | 110801 | China |
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| Shandong Provincial Institute of Cancer Prevention and Treatment | Recruiting | Jinan | Shandong | 250000 | China |
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| QiLu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| Linyi Cancer Hospital | Recruiting | Linyi | Shandong | 276000 | China |
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| Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine | Recruiting | Shanghai | Shanghai Municipality | 20000 | China |
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| Zhongshan Hospital Affiliated to Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200135 | China |
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| The First Affiliated Hospital of Xi An Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
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| Sichuan Tumor Hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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| Second People's Hospital of Yibin City | Recruiting | Yibin | Sichuan | 644000 | China |
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| Tianjin medical university cancer institute&hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Shaoyifu Hospital of Zhejiang University Medical College | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
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