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A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03754244
Recruitment Status : Unknown
Verified March 2019 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Recruiting
First Posted : November 27, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Description
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Brief Summary:
To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: TQB3456 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics
Actual Study Start Date : July 20, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TQB3456
p.o. qd
 Drug: TQB3456
Observe the safety and pk when the subjects take TQB3456 p.o. qd


Outcome Measures
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Primary Outcome Measures :
  1. Dose-Limiting Toxicities（DLT） [ Time Frame: Baseline up to 28 days ]

    an adverse event cccurring after initiation of TQ-B3456 that met any following criteria：

    1. >=Grade 3 of non-hematology toxicity
    2. Grade 4 hematology toxicity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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 Criteria:

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

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754244


Locations
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China, Shanghai
No. 241 Huaihai West Road, Xuhui District, Shanghai Recruiting
Shanghai, Shanghai, China, 200030
Contact: bao hui han, doctor    13917833343    18930858216@163.com   
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
More Information
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03754244    
Other Study ID Numbers: TQB3456-I-01
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases