Study to Investigate the Absorption, Metabolism and Excretion of [14C] AC0010 in Patients With Advanced NSCLC

NCT03001609 | Completed Phase 1

• 1 other identifier: AC201606AVTN06
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate Pharmacokinetics parameters of a single dose \[14C\] AC0010 in male Patients With Advanced NSCLC.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics, Cumalative excretion and Metabolite of 14C-labeled AC0010

  Pharmacokinetics of 14C-labeled AC0010 Radioactivity in whole blood and plasma,Cumulative excretion of 14C-labeled AC0010 radioactivity in feces and urine,Metabolite identification of 14C-labeled AC0010 in plasma, urine and feces

  up to 8 Days

Secondary Outcomes (2)

• Quantitative analysis of plasma concentrations of unlabeled AC0010

  up to 8 Days

• Number of adverse events (AE) experienced by patients

  up to 8 Days

Study Arms (1)

AC0010

EXPERIMENTAL

each participant will be given a single dose of 14C-labeled AC0010

Drug: AC0010

Interventions

AC0010 DRUG

Oral dose of 14C-labeled AC0010 suspension including 200 mg/83μCi\[14C\]

Also known as: 14C-labeled AC0010 oral, 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
• 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)
• BUN≤1.5xULN
• 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

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 intaking of pitaya, pomelo, grapefruit, orange, mango and other fruit may affect drug metabolizing enzymes or juice
• Within 2 days prior to the treatment intaking of coffee, tea, cola, chocolate, or other caffeine containing beverages, alcoholic beverages and / or other alcoholic products
• 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

Sponsors & Collaborators

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

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, 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

• Feng Shao, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Yongqian Shu, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Lihua Bao, 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: December 23, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

CN (1)