Advanced Malignant TumorPhase 2NCT04412564
A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
A Phase 2 study testing TQ-B3101 in people with Advanced Malignant Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 36 sites in China.
Trial summary
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumor
- What is being tested?
- TQ-B3101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 36 sitesChina
- Study dates
- 5 Aug 2020to Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 1 country.
Hongming Pan, Doctor contact
36 sites in 1 country
China36 sites, 36 recruiting
- Not yet recruiting
AnYang Tumor Hospital
Anyang, Henan, 455000
Junsheng Wang, 1207741934@qq.com
Junsheng Wang
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yan Wang, Doctor, wangyanyifu@126.com
Yan Wang, Doctor
- Not yet recruiting
The Fifth Medical Center of PLA Ceneral Hospital
Beijing, Beijing Municipality, 100071
Hongjun Gao, gaohj6709@hotmail.com
Hongjun Gao
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Zhuo Yu, Doctor, yuzhuo@vip.sina.com
Zhuo Yu, Doctor
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410006
Lin Wu, Doctor, wulin-calf@vip.163.com
Lin Wu, Doctor
- Not yet recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027
Yang Zhang, Doctor, 1592855479@qq.com
Yang Zhang, Doctor
- Not yet recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350011
Wu Zhuang, zhuangwu2008@126.com
Wu Zhuang
- Not yet recruiting
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 501195
Weidong Li, lwdlyn_hky@126.com
Weidong Li
- Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Jianhang He, Doctor, 020-83062807, hejx@vip.163.com
Jianhang He, Doctor
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, 310016
Hongming Pan, Doctor, Shonco@sina.cn
Hongming Pan, Doctor
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yiping Zhang, zyp352@163.com
Yiping Zhang
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Yan Yu, Doctor, gpyuyan@163.com
Yan Yu, Doctor
- Not yet recruiting
Anhui Chest Hospital
Hefei, Anhui, 230022
Xuhong Min, 1320722827@qq.com
Xuhong Min
- Not yet recruiting
The Second Hospital of Anhui medical University
Hefei, Anhui, 230601
Zhendong Chen, chenzhendong@csco.org.cn
Zhendong Chen
- Not yet recruiting
The First People's Hospital of Kashgar Prefecture
Kashgar Prefecture, Xinjiang Uygur Autonomous Region, 844000
Yuhua Wu, 68161592@qq.com
Yuhua Wu
- Not yet recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Rixin Chen, crxcyh@163.com
Rixin Chen
- Not yet recruiting
Luoyang Central Hospital Affiliated to Zhenghzou University
Luoyang, Henan, 471009
Zhidong Pei, peizhidong2728@163.com
Zhidong Pei
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000
Yongqian Shu, Doctor, shuyongqian@csco.org.cn
Yongqian Shu, Doctor
- Not yet recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210000
Wei Gu, Doctor, cxw0028@126.con
Wei Gu, Doctor
- Not yet recruiting
Nanyang First People's Hospital
Nanyang, Henan, 473000
Xulin Zhao, zlkzxl@163.com
Xulin Zhao
- Recruiting
Shanghai Jiaotong University Affiliated Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu, Doctor, Shun_lu@hotmail.com
Shun Lu, Doctor
- Not yet recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Qi Li, Doctor, leeqi2001@hotmail.com
Qi Li, Doctor
- Not yet recruiting
First Affiliated Hospital, School of Medicine, Shihezi University
Shihezi, Xinjiang Uygur Autonomous Region, 832000
Ping Gong, Doctor
Ping Gong, Doctor
- Not yet recruiting
Shanxi Bethuen Hospital
Taiyuan, Shanxi, 030000
Mengxian Zhang, Doctor, zhangmx73@163.com
Mengxian Zhang, Doctor
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Diansheng Zhong, zhongdsh@hotmail.com
Diansheng Zhong
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Kai Li, Doctor, likai_fnk@163.com
Kai Li, Doctor
- Not yet recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830011
Rui Mao, Doctor, 42492768@qq.com
Rui Mao, Doctor
- Not yet recruiting
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830011
Chunling Liu, liudeyouxiang66@163.com
Chunling Liu
- Not yet recruiting
Weihai Central Hospital
Weihai, Shandong, 264400
Houqiang Li, wendengliuhouqiang@163.com
Houqiang Li
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Yanping Hu, h-y-p@126.com
Yanping Hu
- Not yet recruiting
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi’an, Shanxi, 710038
Haizhou Su, Doctor, suhc@fummu.edu.cn
Haizhou Su, Doctor
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Yu Yao, Doctor
Yu Yao, Doctor
- Not yet recruiting
Xi'an Chest Hospital
Xi’an, Shanxi, 710100
Juanwen Lian, L85325060@163.com
Juanwen Lian
- Not yet recruiting
Xiangyang First People's Hospital
Xiangyang, Hubei, 441099
Xinxuan Wen, 1779477582@qq.com
Xinxuan Wen
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Shundong Cang, Doctor, cangshundong@163.com
Shundong Cang, Doctor
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Zhiyong Ma
Zhiyong Ma
About this study
Official title: 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.
- Conditions
- Advanced Malignant Tumor
- Being tested
- TQ-B3101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3101Drug
TQ-B3101 is a ALK inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| TQ-B3101 capsules | Experimental | TQ-B3101 capsules 300mg bid administered orally in 28-day cycle. Receives: Drug: TQ-B3101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Measured: up to 48 weeks
Adverse events (AE) and serious adverse events (SAE)
The occurrence of all adverse events (AE) and serious adverse events (SAE).
Measured: up to 48 weeks
Secondary outcomes (3)
Progression free survival (PFS)
PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Measured: up to 48 weeks
Disease control rate (DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: 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.
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start5 Aug 2020
- Primary completion31 Mar 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412564
- Sponsor's protocol ID
- TQ-B3101-II-03
- Status last verified
- Aug 2020
- First submitted
- 28 May 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
- ClinicalTrials.gov ID
- NCT04412564
- Acronym / sponsor ID
- TQ-B3101-II-03
- Conditions
- Advanced Malignant Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQ-B3101 capsules | Experimental | Drug: TQ-B3101TQ-B3101 capsules 300mg bid administered orally in 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQ-B3101TQ-B3101 is a ALK inhibitor. | Drug | TQ-B3101 capsules |
Primary outcome
Overall response rate (ORR)
Time frame: up to 48 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR).
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).
3 secondary outcomes
Progression free survival (PFS)
Time frame: up to 48 weeks
Disease control rate (DCR)
Time frame: up to 48 weeks
Overall survival (OS)
Time frame: up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongming Pan, Doctor contact
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQ-B3101 in people with Advanced Malignant Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 36 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongming Pan, Doctor (Shonco@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.