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

Advanced Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04412564
• Other study ID #: TQ-B3101-II-03
• Status: Recruiting
• Phase: Phase 2
• Start date: August 5, 2020
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Hongming Pan, Doctor
• Email: Shonco[@]sina.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignant Tumor
• Neoplasms

Intervention

Drug:
• TQ-B3101
TQ-B3101 is a ALK inhibitor.

Locations

Country	Name	City	State
China	AnYang Tumor Hospital	Anyang	Henan
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	The Fifth Medical Center of PLA Ceneral Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Cancer Center of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Chest Hospital	Hefei	Anhui
China	The Second Hospital of Anhui medical University	Hefei	Anhui
China	The First People's Hospital of Kashgar Prefecture	Kashgar Prefecture	Xinjiang Uygur Autonomous Region
China	Liuzhou People's Hospital	Liuzhou	Guangxi Zhuang Autonomous Region
China	Luoyang Central Hospital Affiliated to Zhenghzou University	Luoyang	Henan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Nanyang First People's Hospital	Nanyang	Henan
China	Shanghai General Hospital	Shanghai	Shanghai
China	Shanghai Jiaotong University Affiliated Chest Hospital	Shanghai	Shanghai
China	First Affiliated Hospital, School of Medicine, Shihezi University	Shihezi	Xinjiang Uygur Autonomous Region
China	Shanxi Bethuen Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang Uygur Autonomous Region
China	The Affiliated Cancer Hospital of Xinjiang Medical University	Urumqi	Xinjiang Uygur Autonomous Region
China	Weihai Central Hospital	Weihai	Shandong
China	Hubei Cancer Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The Second Affiliated Hospital of PLA Air Force Military Medical University	Xi'an	Shanxi
China	Xi'an Chest Hospital	Xi'an	Shanxi
China	Xiangyang First People's Hospital	Xiangyang	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	Percentage of subjects achieving complete response (CR) and partial response (PR).	up to 48 weeks
Primary	Adverse events (AE) and serious adverse events (SAE)	The occurrence of all adverse events (AE) and serious adverse events (SAE).	up to 48 weeks
Secondary	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
Secondary	Disease control rate (DCR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 48 weeks
Secondary	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