Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

ASK120067 (80 mg orally, twice daily) plus placebo Gefitinib (250 mg orally, once daily), in accordance with the randomization schedule.

Gefitinib (250 mg orally, once daily) plus placebo ASK120067 (80 mg orally, twice daily), in accordance with the randomization schedule.

ASK120067 (80 mg orally twice daily) . A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

ASK120067

The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

Placebo Gefitinib 250 mg

Gefitinib (250 mg orally, once daily) , A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit acording to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

Placebo ASK120067orally 80mg twice daily . A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

Placebo ASK120067

Tingting Song

Luwei Han

Yuankai Shi

Baolan Li

Jifeng Feng

To assess the efficacy and safety of ASK120067 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor Gefitinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

Triple (Participant, Investigator, Outcomes Assessor)

ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC

A Phase III,Double-Blind, Randomised Study to Assess the Efficacy and Safety of ASK120067 Versus Gefitinib as First-Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy prior to progression and was used to assess the efficacy of single agent ASK120067 compared with Gefitinib as measured by PFS.

ORR was defined as the number (%) of patients with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of ASK120067 compared with Gefitinib defined as the number (%) of patients with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of ASK120067 compared with Gefitinib

Duration of response was defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression and was used to further assess the efficacy of ASK120067 compared with Gefitinib

The DCR was defined as the percentage of participants who had a best overall response (BOR) of Complete response (CR), Partial response (PR) or Stable disease (SD) ≥6 weeks prior to any Progressive disease (PD) event and was used to further assess the efficacy of ASK120067 compared with Gefitinib

The Depth of response was defined as the relative change in the sum of the longest diameters of Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions (TLs) at the nadir, in the absence of new lesions (NLs) or progression of Non-target lesions

Overall survival was defined as the time from the date of randomisation until death from any cause and was used to further assess the efficacy of ASK120067 compared with Gefitinib

Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

patients take ASK120067 orally once per day at different dose

patients take ASK120067 orally once per day at 40,80,160,240,320,480mg

Kai Li

ASK120067 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.

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer

A Phase I/II Study to Assess the Safety,Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Patients With Locally Advanced or Metastatic T790M Mutation-positive Non-Small Cell Lung Cancer Who Have Progressed Following Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent

Evaluation of objective response rate assessed by RECIST 1.1

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

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

Duration of response assessed by RECIST 1.1

Evaluation of Disease control rate assessed by RECIST 1.1

defined as the time from date of first dose until date of death due to any cause

Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out Cmax

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out tmax

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day1 to figure out AUC

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out terminal rate constant

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out clearance

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out half life

Collect plasma concentrations of f ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out volume of distribution

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out mean resistance time

Cmax of ASK120067 and 1 metabolite at steady state following multiple doses

Tmax of ASK120067 and 1 metabolite at steady state following multiple doses

Cmin of ASK120067 and 1 metabolite at steady state following multiple doses

AUC of ASK120067 and 1 metabolite at steady state following multiple doses

Clearance of ASK120067 and 1 metabolite at steady state following multiple doses

Accumulation ratio of ASK120067 and 1 metabolite following multiple doses

Time dependency of ASK120067 and 1 metabolite following multiple doses

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC	NCT04143607	Locally Advance...	ASK120067 Placebo Gefitin... Gefitinib Placebo ASK1200...	18 Years -	Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer	NCT03502850	Locally Advance...	ASK120067	18 Years - 75 Years	Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for ask120067

Every month we try and update this database with for ask120067 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 ask120067

Every month we try and update this database with for ask120067 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 ask120067 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.