A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
NCT ID: NCT04481607
Last Updated: 2022-01-10
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
96 participants
INTERVENTIONAL
2020-08-24
2022-12-31
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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TQB3454 tablets
TQB3454 tablets administered orally once. Then TQB3454 tablets administered orally, once daily in 28-day cycle after 7 days of first administration.
TQB3454
TQB3454 tablets is a small molecule oral drug.
Interventions
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TQB3454
TQB3454 tablets is a small molecule oral drug.
Eligibility Criteria
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Inclusion Criteria
2\. Advanced solid tumors or hematological malignancy. 3. Adequate laboratory indicators. 4. No pregnant or breastfeeding women, and a negative pregnancy test. 5. Understood and Signed an informed consent form.
Exclusion Criteria
1. Has received IDH1 mutation inhibitor.
2. Has received systemic anti-tumor therapy or radiotherapy within 14 days before the first dose.
3. Has received oral targeted drugs, less than 5 drug half-lives from first dose.
4. The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 2, except for hair loss.
3.Complicated disease and medical history:
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1. Active hepatitis B or hepatitis C.
2. Abnormal kidney.
3. Abnormal cardiovascular and cerebrovascular.
4. Abnormal gastrointestinal.
5. Has medical history of immunodeficiency.
6. Has bleeding (hemoptysis), coagulopathy, or been using warfarin, aspirin, and other antiplatelet agglutination drugs.
7. Has uncontrollable systemic bacterial, fungal or viral active infections.
8. Has medical history of idiopathic pulmonary fibrosis,or tissue pneumonia.
9. Has allergic constitution or previous severe allergy; or known allergy to ingredients of study drug.
10. Has neurological or mental disorders.
11. Has a history of drug abuse or drug addict.
12. Has received major surgery, open biopsy, or obvious traumatic injury within 4 weeks before the first dose.
13. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
4\. Has participated in other clinical trials within 30 days before participating in this trial.
5\. Female patients during pregnancy or lactation. 6. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
7\. criteria for solid tumors:
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1. Has any signs of bleeding constitution.
2. Has any CTCAE ≥ grade 3 bleeding or bleeding event,within 4 weeks before the first dose.
3. Has unhealed wounds, fractures, active ulcers of the stomach and duodenum, ulcerative colitis and other digestive tract diseases.
4. Imaging (CT or MRI) shows that the tumor has invaded the circumference of important blood vessels.
5. Has uncontrollable pleural effusion, pericardial effusion or ascites that still need repeated drainage.
criteria for blood tumor:
a) Has severe life-threatening leukemia complications.
18 Years
75 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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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The Affiliated Hosptial of Xuzhou Medical University
Xuzhou, Jiangsu, China
Tianjing Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hosptial Zhejiang University School of Medical
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQB3454-I-02
Identifier Type: -
Identifier Source: org_study_id
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