Clinical trial NCT04412564: A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
Official title: A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Malignant Tumor
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: up to 48 weeks
measure: Adverse events (AE) and serious adverse events (SAE)
timeFrame: up to 48 weeks
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: up to 48 weeks
measure: Disease control rate (DCR)
timeFrame: up to 48 weeks
measure: Overall survival (OS)
timeFrame: up to 48 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Chest Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui medical University
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: The Fifth Medical Center of PLA Ceneral Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Cancer Center of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi Zhuang Autonomous Region
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: AnYang Tumor Hospital
state: Henan
city: Luoyang
country: China
facility: Luoyang Central Hospital Affiliated to Zhenghzou University
state: Henan
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang First People's Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Weihai
country: China
facility: Weihai Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Jiaotong University Affiliated Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethuen Hospital
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of PLA Air Force Military Medical University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Chest Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Kashgar Prefecture
country: China
facility: The First People's Hospital of Kashgar Prefecture
state: Xinjiang Uygur Autonomous Region
city: Shihezi
country: China
facility: First Affiliated Hospital, School of Medicine, Shihezi University
state: Xinjiang Uygur Autonomous Region
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang Uygur Autonomous Region
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang Uygur Autonomous Region
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: