Status:
UNKNOWN
A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Malignant Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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.
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04412564
Start Date
August 5 2020
End Date
September 1 2021
Last Update
August 18 2020
Active Locations (36)
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1
Anhui Chest Hospital
Hefei, Anhui, China, 230022
2
The Second Hospital of Anhui medical University
Hefei, Anhui, China, 230601
3
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
4
The Fifth Medical Center of PLA Ceneral Hospital
Beijing, Beijing Municipality, China, 100071