Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC
NCT ID: NCT03300115
Last Updated: 2019-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
222 participants
INTERVENTIONAL
2017-05-18
2020-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AC0010
Each participant will be given AC0010 300mg bid.
AC0010
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).
Interventions
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AC0010
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent non-small cell lung cancer which cannot receive radical surgery and radiotherapy.
3. 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.
4. Patients without CNS metastases or asymptomatic patients with brain metastases. The number of CNS metastases focus≤2, maximum diameter \<10mm.
5. 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.
6. 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.
7. 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.
8. The patient must have good organ function, including meeting the laboratory test requirements at screening.
9. 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).
10. ECOG score: 0-1 points. No deterioration in the last 2 weeks.
11. Expected survival time:\> 12 weeks.
12. Patients who can cooperate with the observation of adverse events and efficacy.
13. Patients or their legal representatives have signed a written informed consent form.
Exclusion Criteria
2. HIV antibody positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
3. A past history of interstitial lung disease and radiation pneumonia.
4. 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.
5. 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;
6. In addition to NSCLC, patients who have been diagnosed with another and/or treatment-requiring malignant disease in recent 5 years (this exclusion criterion does not include the following circumstances: completely resected basal cell and squamous cell skin cancer, inert malignant tumor currently requiring no treatment, and any type of completely resected carcinoma in situ).
Patients who have used high-dose glucocorticoids or other immunosuppressive agents within 1 month prior to screening.
7. 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.
8. Patients who have previously administered third-generation EGFR-TKI drugs (e.g.,AZD9291, Avitinib, CO-1686, HM61713, etc.).
9. Patients who have been registered and received the study treatment or withdrawn from the study cannot be enrolled.
10. Pregnant or lactating women.
11. 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.
12. Patients who are considered by the investigator as inappropriate to participate in the study.
18 Years
75 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Hangzhou ACEA Pharmaceutical Research Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yilong Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Daping Hospital,Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Medical College of HUST
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shandong Cancer Hospital
Jinan, Shandong, China
Tangdu Hospital
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jian Fang
Role: primary
Junling Li
Role: primary
Zhefeng Liu
Role: primary
Yong He
Role: primary
Cheng Huang
Role: primary
Yilong Wu
Role: primary
Guosheng Feng
Role: primary
Yanqiu Zhao
Role: primary
Yuan Chen
Role: primary
Conghua Xie
Role: primary
Peiguo Cao
Role: primary
Chengping Hu
Role: primary
Jian'an Huang
Role: primary
Buhai Wang
Role: primary
Ying Cheng
Role: primary
Jiuwei Cui
Role: primary
Zhehai Wang
Role: primary
Helong Zhang
Role: primary
Zongan Liang
Role: primary
Changli Wang
Role: primary
Jun Chen
Role: primary
Limin Wang
Role: primary
Hongming Pan
Role: primary
Jianjin Huang
Role: primary
Yiping Zhang
Role: primary
Other Identifiers
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AC201602AVTN03
Identifier Type: -
Identifier Source: org_study_id
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