Study Stopped
The enrolment task cannot be gotten within the planned time.It mainly includes patients with non-small cell lung cancer failed in standard treatment,with a short survival period.It is hard to obtain observational endpoints for bone-related events.
A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics
1 other identifier
interventional
1
1 country
1
Brief Summary
To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 nonsmall-cell-lung-cancer
Started Sep 2020
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedApril 7, 2022
March 1, 2022
1.4 years
November 23, 2018
March 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Dose-Limiting Toxicities（DLT）
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
Baseline up to 28 days
Study Arms (1)
TQB3456
EXPERIMENTALp.o. qd
Interventions
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
No. 241 Huaihai West Road, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2018
First Posted
November 27, 2018
Study Start
September 24, 2020
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
April 7, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share