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Preliminary Evaluation of Safety and Efficacy by [14C] AC0010 Trail and Subsequent AC0010 Treatment

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ClinicalTrials.gov Identifier: NCT03053219
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hangzhou ACEA Pharmaceutical Research Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced NSCLC who participant in [14C] AC0010 ADME.

Condition or disease Intervention/treatment Phase
Carcinoma,Non-Small-Cell Lung Drug: AC0010 Phase 1

Detailed Description:
The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced NSCLC who participant in [14C] AC0010 ADME (absorption, distribution, metabolism and excretion) trial and subsequent receiving AC0010 treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Randomized, Single-Center Study to Preliminary Evaluation of Safety and Efficacy of Patients Who Participant in [14C] AC0010 Trail and Subsequent Receiving AC0010 Treatment
Study Start Date : November 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: AC0010
each participant will be given AC0010 300mg bid
Drug: AC0010
Oral dose of 300mg bid,the two doses are advised to be administered at an interval of 12 hours
Other Name: AC0010MA




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months ]
    To assess the overall Objective Response Rate(ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months ]
    To assess the Progression Free Survival(PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.

  2. Disease control rate [ Time Frame: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months ]
    To assess the Disease control rate(DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.

  3. Number of adverse events (AE) experienced by patients to assess safety [ Time Frame: From date of Signed informed consent forms until 30 days after disease progression, intolerable toxicity or withdrawal from study, approximately up to 18 months) ]
    To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed and dated informed consent
  • histologically or cytologically confirmed diagnosis of local advanced or recurrent NSCLC
  • failed to the treatment of EGFR-TKI and harbored T790M mutation
  • male, Age 18~ 65, have a body mass index (BMI)>19 kg/m2
  • Eastern Cooperative Oncology Group performance status(ECOG PS):0-1,Life expectancy of more than 3 months
  • main organs function is normal, laboratory values as listed below: blood test without blood transfusion within 14 days

    1. Haemoglobin >100 g/L
    2. Absolute neutrophil count ≥2.0x10^9/L or WBC ≥3.5 x10^9/L
    3. Platelet count ≥ 80x10^9/L
    4. Total bilirubin ≤1.5xULN
    5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)
    6. Serum creatinine ≤1.5xULN or creatinine clearance ratio ≥60 mL/ min
  • Any prior treatment (chemotherapy, radiotherapy or surgery) must be completed over 4 weeks(target therapy over 2 weeks) from the screening; Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03)
  • International normalized ratio (INR) ≤ 1.5
  • Patients and their partners should be willing to use methods of contraception or total abstinence from start of dosing until 6 months after discontinuing of study treatment
  • Patients must withdraw from previous study of [14C] AC0010

Exclusion Criteria:

  • Prior treated with AC0010 or allergic to drug or its formulation ingredients
  • Patients receiving other anti-tumor therapy
  • Impairment of GI disease, renal disorders or liver disease that may significantly alter the absorption and metabolic of AC0010 (e.g., Unable to swallow, liver, kidney or gastrointestinal partial resection, chronic diarrhea and intestinal obstruction)
  • HCVAb positive, active hepatitis B (excluding HBV carriers), Hepatitis virus markers positive and receiving anti-virus drugs
  • Meningeal metastasis; brain metastasis with whole brain radiotherapy; prior received hormones or mannitol for the brain metastasis
  • Previous EGFR-TKI treatment related Interstitial lung disease history
  • Known human immunodeficiency virus infection (HIV), other acquired or congenital immunodeficiency disease, or a history of organ transplantation
  • Any severe and / or uncontrolled active infections
  • Patients receiving concomitant immunosuppressive agents or high-dose corticosteroids
  • Any severe and / or uncontrolled medical conditions
  • Patients being treated with drugs recognized as being inhibitors or inducers of the liver isoenzyme in the last 4 weeks prior to registration in the current study
  • Within 3 days prior to the treatment taking of dragon fruit, pomelo, grapefruit, orange, mango and other fruit may affect drug metabolizing enzymes or juice
  • Major surgery, incisional biopsy or traumatic injuries;
  • Within 4 weeks prior to the screening patients with bleeding ≥ grade 3, non-healing wound, sever ulcer or bone fracture
  • Patients received high dose irradiation treatment or other 14C-labeled drug within 1 year
  • Known a history of alcoholism or drug abuse
  • Investigator judgment that patient is unsuitable to participate in study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053219


Locations
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China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Sponsors and Collaborators
Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Investigators
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Principal Investigator: Lingxiang Liu, Doctor The First Affiliated Hospital with Nanjing Medical University

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Responsible Party: Hangzhou ACEA Pharmaceutical Research Co., Ltd.
ClinicalTrials.gov Identifier: NCT03053219     History of Changes
Other Study ID Numbers: AC201606AVTN07
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases