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each participant will be given a single dose of 14C-labeled AC0010

Oral dose of 14C-labeled AC0010 suspension including 200 mg/83μCi\[14C\]

AC0010

Feng Shao, Doctor

Yongqian Shu, Doctor

Lihua Bao, Doctor

The purpose of this study is to investigate Pharmacokinetics parameters of a single dose \[14C\] AC0010 in male Patients With Advanced NSCLC.

The purpose of this study is to investigate the Absorption, Metabolism, Excretion and Pharmacokinetics of a single dose \[14C\] AC0010 in male Patients With Advanced NSCLC.

Study to Investigate the Absorption, Metabolism and Excretion of [14C] AC0010 in Patients With Advanced NSCLC

An Open-Label, Non-Randomized, Single-Center Study to Determine the Absorption, Metabolism and Excretion of A Single Dose [14C] AC0010 in Patients With Advanced NSCLC

Pharmacokinetics of 14C-labeled AC0010 Radioactivity in whole blood and plasma,Cumulative excretion of 14C-labeled AC0010 radioactivity in feces and urine,Metabolite identification of 14C-labeled AC0010 in plasma, urine and feces

Quantitative analysis of plasma concentrations of unlabeled AC0010 using a validated LC-MS/MS method

Number of adverse events (AE) experienced by patients to assess safety and tolerability

Hangzhou ACEA Pharmaceutical Research Co., Ltd.

Mitogens

patients receiving avitinib treatment Qd, at different dose stages

patients take avitinib orally once per day at different dose

Yuxiang Ma, MD

Li Zhang, professor

AC0010 Maleate Capsules is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor.Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the activities of EGFR tyrosine kinase phosphorylation, block the sigal signal transduction system of EGFR, and close the function of ras/raf/MAPK downstream. at last block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010 Maleate Capsules has three characters: 1. Irreversible combination with EGFR; 2.Efficient suppress the EGFR mutant tumor cell and has no suppression to EGFR wild-type cell; 3. Efficient suppress the EGFR T790M drug-resistant mutation tumor cell.

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumor has started to re-grow following that treatment. This is the first time that this drug is used or tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

This study is a multicenter, open-label, two-stage phase I clinical trial. Trial including single-dose and successive-dose tolerance research, single-dose and successive-dose pharmacokinetic research, food bioavailability study, exploration of different dosing methods and tentative evaluation for clinical efficacy. Stage one is a dose escalation study, using the modified Fibonacci methods. 7 dose level are set, respectively are 50mg/d 100mg/d 200mg/d 350mg/d 550mg/d 850mg/d and 1100mg/d. Three patients are enrolled in each dose level, the observed indicator is dose-limited toxicity. No DLT occurred of all 3 patients, the dose escalate to next level. 1/3 DLT observed, 3 more patients are enrolled in the level, if no DLT is observed, the dose escalated to next level, if DLT occurs again, escalation stops. 2/3 DLT are observed, escalation stops. A recommend phase II dose level will acquire by this method. Stage two is a multicenter, open label, one arm successive dose clinical trial, based on the dosing level and method acquired in stage one, for further safety evaluation and tentative evaluation of clinical efficacy.

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Advanced Non Small Cell Lung Cancer

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent

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

Plasma concentrations of AC0010 and 4 metabolites and pharmacokinetic parameters following single dose with fast in D1 and fed in D4 (Cmax, tmax, AUC, terminal rate constant, clearance, half life, volume of distribution and mean resistance time)

Plasma concentrations of AC0010 and 4 metabolites and pharmacokinetic parameters following multiple doses (steady state Cmax, tmax, Cmin AUC, clearance, accumulation ratio and time dependency)

Evaluation of tumour response, duration of response, tumour shrinkage, progression free survival and overall survival as assessed by RECIST 1.1

Acea Bio (Hangzhou) Co., Ltd.

Sun Yat-sen University

Professor

Phase 1: AC0010 will be administered in escalating dosages in a period of 28-day cycles.

Phase 2: AC0010 will be administered twice-daily at RP2D.

Yilong Wu, MD.

AC0010 is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral AC0010; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral AC0010; to assess the safety and efficacy of AC0010 in previously treated mutant EGFR in NSCLC patients with EGFR T790M mutation.

Lung cancer remains the most common cancer worldwide with non-small cell lung cancer (NSCLC) accounting for 85% of cases. Molecularly targeted therapies have proven to be superior to chemotherapy for NSCLC patients whose tumors have mutations in EGFR. Recent studies have established tyrosine kinase inhibitors (TKIs) as the gold standard for treating EGFR-mutation-positive NCSLC. However, patients on TKIs eventually progress, and in approximately 50% of cases, progression is due to development of an additional mutation called T790M. AC0010 may provide an effective therapy for a patient population with few alternative treatment options. Pre-clinical data demonstrated that AC0010 inhibits T790M. It is anticipated that AC0010 may promote cell death in tumor cells with the T790M mutation, thus providing possible therapeutic benefit in patients who have developed T790M-mediated resistance to previous TKIs.

This is a two-part, open-label study of oral AC0010 administered twice-daily in previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as erlotinib, gefitinib or afatinib.

This study will include 2 parts:

phase 1 : Dose-escalation Period with 28-day cycles; Optional Treatment Extension Period starting on Day 29

phase 2 : Evaluation of activity and safety in patients with the EGFR T790M mutation

Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010 in Patients With EGFR T790M Positive NSCLC

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Patients With EGFR T790M Positive Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With EGFR TKIs

To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

To assess the duration of response (DOR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

To assess the progression-free survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

To assess the disease control rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

To assess the overall survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

Guangdong Provincial People's Hospital

Each participant will be given AC0010 300mg bid.

After subjects prove eligible after screening and are enrolled, they are given AC0010 300 mg Bid (the two doses are advised to be administered at an interval of 12 hours), receive evaluation of safety indicators every 3 weeks, efficacy evaluation every 6 weeks until disease progression or intolerable toxicities or withdrawal from the trial. (If the investigator suspects disease progression, CT or MRI may be performed in advance; if the patient does not have disease progression, subsequent efficacy evaluation will proceed still according to the protocol).

Wanhong Xu, PhD

Jian Fang

Junling Li

Zhefeng Liu

Yong He

Cheng Huang

Yilong Wu

Guosheng Feng

Yanqiu Zhao

Yuan Chen

Conghua Xie

Peiguo Cao

Chengping Hu

Jian'an Huang

Buhai Wang

Ying Cheng

Jiuwei Cui

Zhehai Wang

Helong Zhang

Zongan Liang

Jiang Zhu

Changli Wang

Jun Chen

Limin Wang

Hongming Pan

Jianjin Huang

Yiping Zhang

Yun Fan

Yilong Wu, MD

The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand the sample size based on the fixed dose recommended by the results of previous dose exploration studies in order to further evaluate the study drug's efficacy and safety.

The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand the sample size based on the fixed dose recommended by the results of previous dose exploration studies in order to further evaluate the study drug's efficacy and safety with overall objective tumor response rate (ORR) as the primary efficacy evaluation indicator, and further evaluate subjects' duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and quality of life (QoL). Safety indicators of subjects are further evaluated through adverse events, vital signs and clinical laboratory parameters.

Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC

Single-arm,Multi-center,Phase II Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Mutation-positive Patients With Advanded NSCLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Investigate the Absorption, Metabolism and Excretion of [14C] AC0010 in Patients With Advanced NSCLC	NCT03001609	Carcinoma, Non-...	AC0010	18 Years - 65 Years	Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Advanced Non Small Cell Lung Cancer	NCT02274337	Non-Small Cell ...	AC0010	18 Years - 70 Years	Sun Yat-sen University
Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010 in Patients With EGFR T790M Positive NSCLC	NCT02330367	Metastatic Non-...	AC0010	18 Years - 75 Years	Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010 in Patients With EGFR T790M Positive NSCLC	NCT02330367	Metastatic Non-...	AC0010	18 Years - 75 Years	Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC	NCT03300115	Metastatic Non-...	AC0010	18 Years - 75 Years	Hangzhou ACEA Pharmaceutical Research Co., Ltd.

Spots Global Cancer Trial Database for ac0010

Every month we try and update this database with for ac0010 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 ac0010

Every month we try and update this database with for ac0010 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 ac0010 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.