Status:
TERMINATED
A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.
Eligibility Criteria
Inclusion
- \- progressive or metastatic non-small cell lung cancer that diagnosed Pathologically or cytologically diagnosed patients who have received EGFR tyrosine kinase inhibitor monotherapy (e.g., gefetinib, erlotinib, ecotinib, afatinib) for disease progression EGFR T790M mutation was confirmed ECOG PS≤1 Adequate blood cell counts, kidney function and liver function Patients should participate in the study voluntarily and sign informed consent
Exclusion
- Patients with non-small-cell lung cancer who have received osimertinib or other raw materials or preparations for EGFRT790M mutant drugs Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication; Hepatitis B virus patients with active replication (DNA\> 500 cps / mL), hepatitis C; Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history
- \-
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03754244
Start Date
September 24 2020
End Date
February 28 2022
Last Update
April 7 2022
Active Locations (1)
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1
No. 241 Huaihai West Road, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, China, 200030