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

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ClinicalTrials.gov Identifier: NCT03300115
Recruitment Status : Unknown
Verified February 2019 by Hangzhou ACEA Pharmaceutical Research Co., Ltd..
Recruitment status was:  Recruiting
First Posted : October 3, 2017
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Guangdong Provincial People's Hospital
Information provided by (Responsible Party):
Hangzhou ACEA Pharmaceutical Research Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE October 3, 2017
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE May 18, 2017
Estimated Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
ORR(Objective Response Rate) [ Time Frame: 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. ]
To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
  • DoR (Duration of Response) [ Time Frame: 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. ]
    To assess the duration of response (DOR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
  • PFS (Progression-free survival) [ Time Frame: 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. ]
    To assess the progression-free survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
  • DCR (Disease control rate) [ Time Frame: 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. ]
    To assess the disease control rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
  • OS (Overall survival) [ Time Frame: 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. ]
    To assess the overall survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
  • The lung cancer symptoms and health-related quality of life (HRQoL) [ Time Frame: 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. ]
    To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC
Official Title  ICMJE 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
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Non-small Cell Lung Cancer
Intervention  ICMJE Drug: 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 Name: AC0010MA
Study Arms  ICMJE Experimental: AC0010
Each participant will be given AC0010 300mg bid.
Intervention: Drug: AC0010
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 28, 2017)
222
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 17, 2020
Estimated Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 18-75 years (including 18 and 75 years old).
  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:

  1. Acute hepatitis C, chronic hepatitis C and active hepatitis B (positive HBsAg; HBcAb or HBeAb positive and HBV DNA positive).
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03300115
Other Study ID Numbers  ICMJE AC201602AVTN03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Study Sponsor  ICMJE Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Collaborators  ICMJE Guangdong Provincial People's Hospital
Investigators  ICMJE
Principal Investigator: Yilong Wu, MD Guangdong Provincial People's Hospital
PRS Account Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP