A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors
NCT ID: NCT04128085
Last Updated: 2019-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2019-11-15
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TQB3804
TQB3804 tablet administered orally , once daily in 28-day cycle.
TQB3804
A kind of tyrosine kinase inhibitor.
Interventions
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TQB3804
A kind of tyrosine kinase inhibitor.
Eligibility Criteria
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Inclusion Criteria
7.Adequate organ system function. 8.At least one measurable lesion.
Exclusion Criteria
3.Has interstitial pneumonia. 4.Brain metastases with symptom . 5.Has currently uncontrollable congestive heart failure. 6.Has history of arterial thromboembolism within 6 months. 7.Has any bleeding tendency or coagulopathy within 6 months. 8.Has skin toxicity ≥ grade 2 within 4 weeks. 9.Has serious gastrointestinal diseases within 4 weeks. 10.Has received any major surgery within 4 weeks. 11.Participated in other clinical trials within 4 weeks. 12.Has active viral, bacterial and fungal infections within 4 weeks. 13.Has received any cancer therapy within 4 weeks or 5 times of t1/2. 14.Has ≥ grade 2 toxicity caused by previous anti-tumor treatment. 15. HBsAg positive and HBV DNA positive (≥ULN);HCV antibody and HCV-RNA positive (≥ULN); HIV positive or ≥HIV ULN.
16\. Has multiple factors affecting oral medication. 17. Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study.
18\. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
18 Years
70 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Wu yilong, Doctor
Role: primary
Other Identifiers
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TQB3804-I-01
Identifier Type: -
Identifier Source: org_study_id