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

NCT03053219 | Completed Phase 1

• 1 other identifier: AC201606AVTN07
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma，Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  To assess the overall Objective Response Rate(ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.

  RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months

Secondary Outcomes (3)

• Progression Free Survival

  RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months

• Disease control rate

  RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months

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

  From date of Signed informed consent forms until 30 days after disease progression, intolerable toxicity or withdrawal from study, approximately up to 18 months)

Study Arms (1)

AC0010

EXPERIMENTAL

each participant will be given AC0010 300mg bid

Drug: AC0010

Interventions

AC0010 DRUG

Oral dose of 300mg bid,the two doses are advised to be administered at an interval of 12 hours

Also known as: AC0010MA

AC0010

Eligibility Criteria

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

You may qualify if:

• 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
• Haemoglobin \>100 g/L
• Absolute neutrophil count ≥2.0x10\^9/L or WBC ≥3.5 x10\^9/L
• Platelet count ≥ 80x10\^9/L
• Total bilirubin ≤1.5xULN
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangzhou ACEA Pharmaceutical Research Co., Ltd.: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

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

• Lingxiang Liu, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: February 15, 2017
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)