A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor

August 16, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor

The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Not yet recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • Zhendong Chen
      • Hefei, Anhui, China, 230022
        • Not yet recruiting
        • Anhui Chest Hospital
        • Contact:
        • Principal Investigator:
          • Xuhong Min
    • Beijing
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Yan Wang, Doctor
      • Beijing, Beijing, China, 100071
        • Not yet recruiting
        • The Fifth Medical Center of PLA Ceneral Hospital
        • Contact:
        • Principal Investigator:
          • Hongjun Gao
      • Beijing, Beijing, China, 102218
        • Not yet recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
        • Principal Investigator:
          • Zhuo Yu, Doctor
    • Fujian
      • Fuzhou, Fujian, China, 350011
        • Not yet recruiting
        • Fujian provincial Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Wu Zhuang
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • Jianhang He, Doctor
      • Guangzhou, Guangdong, China, 501195
        • Not yet recruiting
        • Cancer Center of Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • Weidong Li
    • Guangxi Zhuang Autonomous Region
      • Liuzhou, Guangxi Zhuang Autonomous Region, China, 545006
        • Not yet recruiting
        • Liuzhou People's Hospital
        • Contact:
        • Principal Investigator:
          • Rixin Chen
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Yan Yu, Doctor
    • Henan
      • Anyang, Henan, China, 455000
        • Not yet recruiting
        • Anyang Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Junsheng Wang
      • Luoyang, Henan, China, 471009
        • Not yet recruiting
        • Luoyang Central Hospital Affiliated to Zhenghzou University
        • Contact:
        • Principal Investigator:
          • Zhidong Pei
      • Nanyang, Henan, China, 473000
        • Not yet recruiting
        • Nanyang First People's Hospital
        • Contact:
        • Principal Investigator:
          • Xulin Zhao
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
          • zhiyong Ma
        • Principal Investigator:
          • Zhiyong Ma
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Not yet recruiting
        • Hubei Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yanping Hu
      • Xiangyang, Hubei, China, 441099
        • Not yet recruiting
        • Xiangyang First People's Hospital
        • Contact:
        • Principal Investigator:
          • Xinxuan Wen
    • Hunan
      • Changsha, Hunan, China, 410006
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Lin Wu, Doctor
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Yongqian Shu, doctor
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Nanjing First Hospital
        • Contact:
        • Principal Investigator:
          • Wei Gu, Doctor
    • Liaoning
      • Dalian, Liaoning, China, 116027
        • Not yet recruiting
        • The Second Hospital of Dalian Medical University
        • Principal Investigator:
          • Yang Zhang, Doctor
        • Contact:
    • Shandong
      • Weihai, Shandong, China, 264400
        • Not yet recruiting
        • Weihai Central Hospital
        • Contact:
        • Principal Investigator:
          • Houqiang Li
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Not yet recruiting
        • Shanghai General Hospital
        • Contact:
        • Principal Investigator:
          • Qi Li, Doctor
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Jiaotong University Affiliated Chest Hospital
        • Contact:
        • Principal Investigator:
          • Shun Lu, Doctor
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Bethuen Hospital
        • Contact:
        • Principal Investigator:
          • Mengxian Zhang, Doctor
      • Xi'an, Shanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Yu Yao, Doctor
      • Xi'an, Shanxi, China, 710038
        • Not yet recruiting
        • The Second Affiliated Hospital of PLA Air Force Military Medical University
        • Contact:
        • Principal Investigator:
          • Haizhou Su, Doctor
      • Xi'an, Shanxi, China, 710100
        • Not yet recruiting
        • Xi'an Chest Hospital
        • Contact:
        • Principal Investigator:
          • Juanwen Lian
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute and Hospital
    • Xinjiang Uygur Autonomous Region
      • Kashgar Prefecture, Xinjiang Uygur Autonomous Region, China, 844000
        • Not yet recruiting
        • The First People's Hospital of Kashgar Prefecture
        • Contact:
        • Principal Investigator:
          • Yuhua Wu
      • Shihezi, Xinjiang Uygur Autonomous Region, China, 832000
        • Not yet recruiting
        • First Affiliated Hospital, School of Medicine, Shihezi University
        • Contact:
          • Ping Gong, Doctor
        • Principal Investigator:
          • Ping Gong, Doctor
      • Urumqi, Xinjiang Uygur Autonomous Region, China, 830011
        • Not yet recruiting
        • First Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Rui Mao, Doctor
      • Urumqi, Xinjiang Uygur Autonomous Region, China, 830011
        • Not yet recruiting
        • The Affiliated Cancer Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Chunling Liu
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Yiping Zhang
        • Contact:
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University
        • Principal Investigator:
          • Hongming Pan, Doctor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQ-B3101 capsules
TQ-B3101 capsules 300mg bid administered orally in 28-day cycle.
Drug: TQ-B3101
TQ-B3101 is a ALK inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: up to 48 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR).
up to 48 weeks
Adverse events (AE) and serious adverse events (SAE)
Time Frame: up to 48 weeks
The occurrence of all adverse events (AE) and serious adverse events (SAE).
up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: up to 48 weeks
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)
Time Frame: up to 48 weeks
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 48 weeks
Overall survival (OS)
Time Frame: up to 48 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2020

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 16, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ-B3101-II-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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