Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3101 capsules | Experimental | TQ-B3101 capsules 300mg bid administered orally in 28-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3101 | Drug | TQ-B3101 is a ALK inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Percentage of subjects achieving complete response (CR) and partial response (PR). | up to 48 weeks |
| Adverse events (AE) and serious adverse events (SAE) | The occurrence of all adverse events (AE) and serious adverse events (SAE). | up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause. | up to 48 weeks |
| Disease control rate (DCR) |
Not provided
Inclusion Criteria:
-1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
2. Understood and signed an informed consent form. 3. Histologically or cytologically confirmed advanced malignant solid tumors. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception.
Exclusion Criteria:
1. Has multiple factors affecting oral medication. 2. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 3. Other malignancies occurred within 3 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors.
4. Has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension.
5. Has cardiovascular and cerebrovascular diseases. 6. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose.
7. Has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease.
8. Active hepatitis, HIV positive, syphilis positive. 9. Has a history of psychotropic substance abuse. 10. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongming Pan, Doctor | Contact | Shonco@sina.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Chest Hospital | Not yet recruiting | Hefei | Anhui | 230022 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
| up to 48 weeks |
| Overall survival (OS) | OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. | up to 48 weeks |
| The Second Hospital of Anhui medical University | Not yet recruiting | Hefei | Anhui | 230601 | China |
|
| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | 100021 | China |
|
| The Fifth Medical Center of PLA Ceneral Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100071 | China |
|
| Beijing Tsinghua Changgung Hospital | Not yet recruiting | Beijing | Beijing Municipality | 102218 | China |
|
| Fujian Provincial Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350011 | China |
|
| Cancer Center of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 501195 | China |
|
| The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
|
| Liuzhou People's Hospital | Not yet recruiting | Liuzhou | Guangxi | 545006 | China |
|
| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
|
| AnYang Tumor Hospital | Not yet recruiting | Anyang | Henan | 455000 | China |
|
| Luoyang Central Hospital Affiliated to Zhenghzou University | Not yet recruiting | Luoyang | Henan | 471009 | China |
|
| Nanyang First People's Hospital | Not yet recruiting | Nanyang | Henan | 473000 | China |
|
| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
|
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450008 | China |
|
| Hubei Cancer Hospital | Not yet recruiting | Wuhan | Hubei | 430079 | China |
|
| Xiangyang First People's Hospital | Not yet recruiting | Xiangyang | Hubei | 441099 | China |
|
| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410006 | China |
|
| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Nanjing First Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
|
| The Second Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | 116027 | China |
|
| Weihai Central Hospital | Not yet recruiting | Weihai | Shandong | 264400 | China |
|
| Shanghai Jiaotong University Affiliated Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
|
| Shanghai General Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200080 | China |
|
| Shanxi Bethuen Hospital | Not yet recruiting | Taiyuan | Shanxi | 030000 | China |
|
| The Second Affiliated Hospital of PLA Air Force Military Medical University | Not yet recruiting | Xi’an | Shanxi | 710038 | China |
|
| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710061 | China |
|
| Xi'an Chest Hospital | Not yet recruiting | Xi’an | Shanxi | 710100 | China |
|
| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300052 | China |
|
| Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| The First People's Hospital of Kashgar Prefecture | Not yet recruiting | Kashgar Prefecture | Xinjiang Uygur Autonomous Region | 844000 | China |
|
| First Affiliated Hospital, School of Medicine, Shihezi University | Not yet recruiting | Shihezi | Xinjiang Uygur Autonomous Region | 832000 | China |
|
| First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang Uygur Autonomous Region | 830011 | China |
|
| The Affiliated Cancer Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang Uygur Autonomous Region | 830011 | China |
|
| Sir Run Run Shaw Hospital, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310016 | China |
|
| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310022 | China |
|