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

NCT03300115 | Unknown Phase 2

• 1 other identifier: AC201602AVTN03
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Metastatic Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR(Objective Response Rate)

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

  Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

Secondary Outcomes (5)

• DoR (Duration of Response)

  Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

• PFS (Progression-free survival)

  Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

• DCR (Disease control rate)

  Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

• OS (Overall survival)

  Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

• The lung cancer symptoms and health-related quality of life (HRQoL)

  Every 3 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Study Arms (1)

AC0010

EXPERIMENTAL

Each participant will be given AC0010 300mg bid.

Drug: AC0010

Interventions

AC0010 DRUG

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).

Also known as: AC0010MA

AC0010

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years (including 18 and 75 years old).
• Histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent non-small cell lung cancer which cannot receive radical surgery and radiotherapy.
• The patient has at least one radio graphically (CT, MRI)measurable lesion according to the RECIST criteria for solid tumor response; long-diameter of tumor scanned by CT\&MRI ≥10mm, or short-diameter of metastatic cervical lymph nodes≥15mm. With no radiotherapy and biopsy.
• Patients without CNS metastases or asymptomatic patients with brain metastases. The number of CNS metastases focus≤2, maximum diameter \<10mm.
• Document prove EGFR mutation before treatment of EGFR TKI, or show clinical benefit after treatment of EGFR TKI (PR, CR evaluation according to RECIST or more than half-year SD duration); tumor tissue proved to be EGFR T790M positive mutation by center lab after last treatment.
• Patients need to undergo biopsy of primary or metastatic tumor tissue and provide pathological sections to site's central lab; otherwise, the patients need to undergo biopsy of primary or metastatic tumor tissue in the screening period and provide pathological sections to the site's central laboratory.
• Patients who have previously received first-generation EGFR-TKI (erlotinib, gefitinib, ectectin) treatment and developed resistance and are only allowed to have received one chemotherapy regimen (maintenance treatment with the same drug is allowed; but maintenance treatment with a different drug is not allowed), or are positive for primary T790M mutation but have not received treatment or have only received first-line treatment.
• The patient must have good organ function, including meeting the laboratory test requirements at screening.
• Patients must recover to ≤Grade 1 (CTCAE v4.03)toxicity from the previous treatment (patients with any grade of hair loss are allowed to enter the study).
• ECOG score: 0-1 points. No deterioration in the last 2 weeks.
• Expected survival time:\> 12 weeks.
• Patients who can cooperate with the observation of adverse events and efficacy.
• Patients or their legal representatives have signed a written informed consent form.

You may not qualify if:

• Acute hepatitis C, chronic hepatitis C and active hepatitis B (positive HBsAg; HBcAb or HBeAb positive and HBV DNA positive).
• HIV antibody positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
• A past history of interstitial lung disease and radiation pneumonia.
• Clinically significant abnormalities of resting ECG in rhythm, conduction and morphology, such as complete left bundle branch block, Grade II and above heart block, PR interval\> 250 ms, or myocardial infarction within the past 6 months; there are risk factors leading to prolongation of QTc interval or increasing arrhythmias, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or medical history of sudden death at an age of \< 40 years among the patient's first-degree relatives, and 12-lead ECG QT interval correction Fridericia method (QTcF interval)\> 450 ms for male, \>470ms for female.
• The investigator judges based on safety concerns or clinical study process that the patient had any other condition that is prohibited for participation in the clinical study, such as severe infection/inflammation, intestinal obstruction, inability to swallow medication, social/psychological problems, etc.
• With clinically significant electrolyte abnormalities in laboratory tests;
• Patients who have used high-dose glucocorticoids or other immunosuppressive agents within 1 month prior to screening.
• Interval time between previous EGFR TKI treatment and AC0010 \<8 days or 5 half-time, subject to the long time; Interval time between major surgery /radiotherapy and AC0010 \<4 weeks; Patients who are using any drug known to prolong QT interval or known potent CYP3A4 enzyme inducer or inhibitor within 4 weeks before the first dose.
• Patients who have used high-dose glucocorticoids or other immunosuppressive agents within 1 month prior to screening.
• Patients who have previously administered third-generation EGFR-TKI drugs (e.g.,AZD9291, Avitinib, CO-1686, HM61713, etc.).
• Patients who have been registered and received the study treatment or withdrawn from the study cannot be enrolled.
• Pregnant or lactating women.
• Women with childbearing potential are defined as all women who are physiologically able to have a pregnancy, unless they are using an efficient contraceptive method during treatment and within 7 days after discontinuation of treatment.
• Patients who are considered by the investigator as inappropriate to participate in the study.

Sponsors & Collaborators

• Hangzhou ACEA Pharmaceutical Research Co., Ltd.: lead
• Guangdong Provincial People's Hospital: collaborator

Study Sites (25)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Daping Hospital,Research Institute of Surgery Third Military Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Tongji Medical College of HUST

Wuhan, Hubei, 430000, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, 410000, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250000, China

RECRUITING

Tangdu Hospital

Xi’an, Shanxi, 710000, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Sir Run Run Shaw Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

abivertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yilong Wu, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanhong Xu, PhD

CONTACT

+8657128908600; kayla.liu@aceapharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 3, 2017
• Study Start: May 18, 2017
• Primary Completion: June 17, 2019
• Study Completion: December 17, 2020
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

CN (25)