<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04412564</url>
  </required_header>
  <id_info>
    <org_study_id>TQ-B3101-II-03</org_study_id>
    <nct_id>NCT04412564</nct_id>
  </id_info>
  <brief_title>A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor</brief_title>
  <official_title>A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with&#xD;
      advanced malignant tumor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>Percentage of subjects achieving complete response (CR) and partial response (PR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events (AE) and serious adverse events (SAE)</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>The occurrence of all adverse events (AE) and serious adverse events (SAE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Advanced Malignant Tumor</condition>
  <arm_group>
    <arm_group_label>TQ-B3101 capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TQ-B3101 capsules 300mg bid administered orally in 28-day cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TQ-B3101</intervention_name>
    <description>TQ-B3101 is a ALK inhibitor.</description>
    <arm_group_label>TQ-B3101 capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life&#xD;
        expectancy ≥12 weeks.&#xD;
&#xD;
        2. Understood and signed an informed consent form. 3. Histologically or cytologically&#xD;
        confirmed advanced malignant solid tumors. 4. Adequate organ system function. 5. Patients&#xD;
        need to adopt effective methods of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Has multiple factors affecting oral medication. 2. The toxicity of previous&#xD;
             antitumor treatment is not recovered to ≤ grade 1. 3. Other malignancies occurred&#xD;
             within 3 years, with exception of cured cervical carcinoma in situ, non-melanoma skin&#xD;
             cancer and superficial bladder tumors.&#xD;
&#xD;
             4. Has a history of hypertension, hypertensive encephalopathy or uncontrolled&#xD;
             hypertension.&#xD;
&#xD;
             5. Has cardiovascular and cerebrovascular diseases. 6. Has received radiotherapy,&#xD;
             chemotherapy, surgery less than 4 weeks before the first dose.&#xD;
&#xD;
             7. Has central nervous system metastasis and / or spinal cord compression, cancerous&#xD;
             meningitis, and meningeal disease.&#xD;
&#xD;
             8. Active hepatitis, HIV positive, syphilis positive. 9. Has a history of psychotropic&#xD;
             substance abuse. 10. According to the judgement of the researchers, there are other&#xD;
             factors that subjects are not suitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hongming Pan, Doctor</last_name>
    <email>Shonco@sina.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Anhui Chest Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xuhong Min</last_name>
      <email>1320722827@qq.com</email>
    </contact>
    <investigator>
      <last_name>Xuhong Min</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Anhui medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230601</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhendong Chen</last_name>
      <email>chenzhendong@csco.org.cn</email>
    </contact>
    <investigator>
      <last_name>Zhendong Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yan Wang, Doctor</last_name>
      <email>wangyanyifu@126.com</email>
    </contact>
    <investigator>
      <last_name>Yan Wang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Fifth Medical Center of PLA Ceneral Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hongjun Gao</last_name>
      <email>gaohj6709@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Hongjun Gao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Tsinghua Changgung Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>102218</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhuo Yu, Doctor</last_name>
      <email>yuzhuo@vip.sina.com</email>
    </contact>
    <investigator>
      <last_name>Zhuo Yu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fujian Provincial Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wu Zhuang</last_name>
      <email>zhuangwu2008@126.com</email>
    </contact>
    <investigator>
      <last_name>Wu Zhuang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>501195</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Weidong Li</last_name>
      <email>lwdlyn_hky@126.com</email>
    </contact>
    <investigator>
      <last_name>Weidong Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jianhang He, Doctor</last_name>
      <phone>020-83062807</phone>
      <email>hejx@vip.163.com</email>
    </contact>
    <investigator>
      <last_name>Jianhang He, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liuzhou People's Hospital</name>
      <address>
        <city>Liuzhou</city>
        <state>Guangxi Zhuang Autonomous Region</state>
        <zip>545006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Rixin Chen</last_name>
      <email>crxcyh@163.com</email>
    </contact>
    <investigator>
      <last_name>Rixin Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yan Yu, Doctor</last_name>
      <email>gpyuyan@163.com</email>
    </contact>
    <investigator>
      <last_name>Yan Yu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AnYang Tumor Hospital</name>
      <address>
        <city>Anyang</city>
        <state>Henan</state>
        <zip>455000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Junsheng Wang</last_name>
      <email>1207741934@qq.com</email>
    </contact>
    <investigator>
      <last_name>Junsheng Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Luoyang Central Hospital Affiliated to Zhenghzou University</name>
      <address>
        <city>Luoyang</city>
        <state>Henan</state>
        <zip>471009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhidong Pei</last_name>
      <email>peizhidong2728@163.com</email>
    </contact>
    <investigator>
      <last_name>Zhidong Pei</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nanyang First People's Hospital</name>
      <address>
        <city>Nanyang</city>
        <state>Henan</state>
        <zip>473000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xulin Zhao</last_name>
      <email>zlkzxl@163.com</email>
    </contact>
    <investigator>
      <last_name>Xulin Zhao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Shundong Cang, Doctor</last_name>
      <email>cangshundong@163.com</email>
    </contact>
    <investigator>
      <last_name>Shundong Cang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhiyong Ma</last_name>
    </contact>
    <investigator>
      <last_name>Zhiyong Ma</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yanping Hu</last_name>
      <email>h-y-p@126.com</email>
    </contact>
    <investigator>
      <last_name>Yanping Hu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xiangyang First People's Hospital</name>
      <address>
        <city>Xiangyang</city>
        <state>Hubei</state>
        <zip>441099</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xinxuan Wen</last_name>
      <email>1779477582@qq.com</email>
    </contact>
    <investigator>
      <last_name>Xinxuan Wen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lin Wu, Doctor</last_name>
      <email>wulin-calf@vip.163.com</email>
    </contact>
    <investigator>
      <last_name>Lin Wu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yongqian Shu, Doctor</last_name>
      <email>shuyongqian@csco.org.cn</email>
    </contact>
    <investigator>
      <last_name>Yongqian Shu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wei Gu, Doctor</last_name>
      <email>cxw0028@126.con</email>
    </contact>
    <investigator>
      <last_name>Wei Gu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116027</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yang Zhang, Doctor</last_name>
      <email>1592855479@qq.com</email>
    </contact>
    <investigator>
      <last_name>Yang Zhang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Weihai Central Hospital</name>
      <address>
        <city>Weihai</city>
        <state>Shandong</state>
        <zip>264400</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Houqiang Li</last_name>
      <email>wendengliuhouqiang@163.com</email>
    </contact>
    <investigator>
      <last_name>Houqiang Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai Jiaotong University Affiliated Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shun Lu, Doctor</last_name>
      <email>Shun_lu@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Shun Lu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai General Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Qi Li, Doctor</last_name>
      <email>leeqi2001@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Qi Li, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanxi Bethuen Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mengxian Zhang, Doctor</last_name>
      <email>zhangmx73@163.com</email>
    </contact>
    <investigator>
      <last_name>Mengxian Zhang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of PLA Air Force Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Haizhou Su, Doctor</last_name>
      <email>suhc@fummu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Haizhou Su, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yu Yao, Doctor</last_name>
    </contact>
    <investigator>
      <last_name>Yu Yao, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xi'an Chest Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710100</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Juanwen Lian</last_name>
      <email>L85325060@163.com</email>
    </contact>
    <investigator>
      <last_name>Juanwen Lian</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Diansheng Zhong</last_name>
      <email>zhongdsh@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Diansheng Zhong</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kai Li, Doctor</last_name>
      <email>likai_fnk@163.com</email>
    </contact>
    <investigator>
      <last_name>Kai Li, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Kashgar Prefecture</name>
      <address>
        <city>Kashgar Prefecture</city>
        <state>Xinjiang Uygur Autonomous Region</state>
        <zip>844000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yuhua Wu</last_name>
      <email>68161592@qq.com</email>
    </contact>
    <investigator>
      <last_name>Yuhua Wu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital, School of Medicine, Shihezi University</name>
      <address>
        <city>Shihezi</city>
        <state>Xinjiang Uygur Autonomous Region</state>
        <zip>832000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ping Gong, Doctor</last_name>
    </contact>
    <investigator>
      <last_name>Ping Gong, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang Uygur Autonomous Region</state>
        <zip>830011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Rui Mao, Doctor</last_name>
      <email>42492768@qq.com</email>
    </contact>
    <investigator>
      <last_name>Rui Mao, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Affiliated Cancer Hospital of Xinjiang Medical University</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang Uygur Autonomous Region</state>
        <zip>830011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chunling Liu</last_name>
      <email>liudeyouxiang66@163.com</email>
    </contact>
    <investigator>
      <last_name>Chunling Liu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongming Pan, Doctor</last_name>
      <email>Shonco@sina.cn</email>
    </contact>
    <investigator>
      <last_name>Hongming Pan, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yiping Zhang</last_name>
      <email>zyp352@163.com</email>
    </contact>
    <investigator>
      <last_name>Yiping Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 16, 2020</last_update_submitted>
  <last_update_submitted_qc>August 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04412564
org study id: TQ-B3101-II-03
nct id: NCT04412564
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with
      advanced malignant tumor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate (ORR)
time frame: up to 48 weeks
description: Percentage of subjects achieving complete response (CR) and partial response (PR).
measure: Adverse events (AE) and serious adverse events (SAE)
time frame: up to 48 weeks
description: The occurrence of all adverse events (AE) and serious adverse events (SAE).
measure: Progression free survival (PFS)
time frame: up to 48 weeks
description: PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
measure: Disease control rate (DCR)
time frame: up to 48 weeks
description: Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
measure: Overall survival (OS)
time frame: up to 48 weeks
description: 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.
arm group label: TQ-B3101 capsules
arm group type: Experimental
description: TQ-B3101 capsules 300mg bid administered orally in 28-day cycle.
intervention type: Drug
intervention name: TQ-B3101
description: TQ-B3101 is a ALK inhibitor.
arm group label: TQ-B3101 capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hongming Pan, Doctor
email: Shonco@sina.cn
facility: 
status: Not yet recruiting
contact: 
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contact: 
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contact: 
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facility: 
status: Recruiting
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contact: 
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contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
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facility: 
status: Recruiting
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status: Not yet recruiting
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country: China
responsible party type: Sponsor
mesh term: Neoplasms