Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Aflutinib

Protein Kinase Inhibitors

Enzyme Inhibitors

patients take Alflutinib orally once per day at different dose

Alflutinib

This study is conducted to assess the safety, tolerability and preliminary efficacy of AST2818 in patients with advanced Non Small Cell Lung Cancer (NSCLC).

AST2818 in Advanced Non-Small Cell Lung Cancer With EGFR Mutations

Multiple-Centered Study of AST2818 in Patients With Advanced Non-small Cell Lung Cancer With EGFR Mutations

Evaluation of objective response rate assessed by RECIST 1.1

Duration of response assessed by RECIST 1.1

Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival

Clinical benefit rate was calculated by adding up complete remission, partial remission and stabilization of disease assessed by RECIST 1.1

Progression of tumor was assessed by RECIST 1.1 thereby to evaluate disease control rate

Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, ophthalmic examinations, RECIST1.1, and NCI CTCAE v4.03

Cmax of Alflutinib and 2 metabolites at steady state following multiple doses

tmax of Alflutinib and 2 metabolites at steady state following multiple doses.

Cmin of Alflutinib and 2 metabolites at steady state following multiple doses.

AUC of Alflutinib and 2 metabolites at steady state following multiple doses.

Clearance of Alflutinib and 2 metabolites at steady state following multiple doses.

Accumulation ratio of Alflutinib and 2 metabolites following multiple doses.

Allist Pharmaceuticals, Inc.

patients take Alflutinib orally once per day at dose of 80mg or160mg

Patients take Alflutinib orally once per day at dose of 80 mg or 160 mg

This study is conducted to evaluate the efficacy and safety of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring T790M mutation

This is a multicenter, randomized and open Ⅱb phase study assessing the efficacy and safety of Alflutinib at doses of 80 mg orally /once daily and 160 mg orally /once daily in patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) harboring acquired T790M mutation after EGFR-TKI treatment or primary T790M mutation.

Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients With T790M

Multicenter, Randomized and OpenⅡb Clinical Trials to Evaluate the Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Harbouring T790M Mutation

Evaluation of the objective response rate of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring acquired T790M mutation by prior therapy with an EGFR-TKI or primary T790M mutation assessed by RECIST 1.1

Evaluation of the overall survival of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring acquired T790M mutation by prior therapy with an EGFR-TKI or primary T790M mutation assessed by RECIST 1.1

Evaluation of the duration of response of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring acquired T790M mutation by prior therapy with an EGFR-TKI or primary T790M mutation assessed by RECIST 1.1

Amino Acids

Mitogens

Tyrosine Kinase Inhibitors

Tyrosine

Shi YK

Alflutinib Mesylate Tablets is a Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant mutation tumor cell in Xenograft mouse model. This study aims at local advanced or metastatic non-small cell lung cancer patients with T790M drug-resistant mutation.

This is a Phase I study, to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AST2818 in patients with advanced non-small cell lung cancer who progressed on prior therapy with an epidermal growth factor receptor tyrosine kinase inhibitor agent. The tolerability of AST2818 20 mg/day - 240 mg/day in 14 subjects was observed. 7-days observation period for a single dose and 21-days observation period for multiple doses.

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent

Collect plasma concentrations of Alflutinib and 2 metabolites following single dose at designated time points of Day 1 to figure out Cmax.

Collect plasma concentrations of Alflutinib and 2 metabolites following single dose at designated time points of Day 1 to figure out tmax.

Collect plasma concentrations of Alflutinib and 2 metabolites following single dose at designated time points of Day1 to figure out AUC.

Collect plasma concentrations of Alflutinib and 2 metabolites following single dose at designated time points of Day 1 to figure out terminal rate constant.

Collect plasma concentrations of Alflutinib and 2 metabolites following single dose at designated time points of Day 1 to figure out clearance.

Collect plasma concentrations of Alflutinib and 2 metabolites following single dose at designated time points of Day 1 to figure out half life.

Collect plasma concentrations of Alflutinib and 2 metabolites following single dose at designated time points of Day 1 to figure out volume of distribution.

Collect plasma concentrations of Alflutinib and 2 metabolites following single dose at designated time points of Day 1 to figure out mean resistance time.

Cmax of Alflutinib and 2 metabolites at steady state following multiple doses.

Time dependency of Alflutinib and 2 metabolites following multiple doses.

Progression of tumor was assessed by RECIST 1.1 thereby to evaluate disease progression rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AST2818 in Advanced Non-Small Cell Lung Cancer With EGFR Mutations	NCT03127449	Advanced NSCLC	Alflutinib	18 Years -	Allist Pharmaceuticals, Inc.
Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients With T790M	NCT03452592	Advanced NSCLC ...	Alflutinib	18 Years - 80 Years	Allist Pharmaceuticals, Inc.
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer	NCT02973763	NSCLC	Alflutinib	18 Years - 65 Years	Allist Pharmaceuticals, Inc.
AST2818 in Advanced Non-Small Cell Lung Cancer With EGFR Mutations	NCT03127449	Advanced NSCLC	Alflutinib	18 Years -	Allist Pharmaceuticals, Inc.
Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients With T790M	NCT03452592	Advanced NSCLC ...	Alflutinib	18 Years - 80 Years	Allist Pharmaceuticals, Inc.
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer	NCT02973763	NSCLC	Alflutinib	18 Years - 65 Years	Allist Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for alflutinib

Every month we try and update this database with for alflutinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for alflutinib

Every month we try and update this database with for alflutinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for alflutinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.