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Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment

NCT02161770 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-03-08

No results posted yet for this study

Summary

This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow any patient with mild or moderate hepatic impairment or normal hepatic function, who completes Part A, continued access to AZD9291 after the PK phase and will provide additional safety data.

Conditions

Interventions

DRUG

AZD9291 tablet dosing

Part A - single 80mg oral dose AZD9291 (administered as 1 80mg tablet). Part B - 80mg oral dose AZD9291 od.

PROCEDURE

Pharmacokinetic sampling - AZD9291

Blood sampling to measure AZD9291 pharmacokinetic parameters.

PROCEDURE

Pharmacokinetic sampling - AZ5140 and AZ7550

Blood samples to measure the pharmacokinetic parameters of AZ5104 and AZ7550.

Sponsors & Collaborators

Principal Investigators

  • Yuri Rukazenkov · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-22
Primary Completion
2017-05-16
Completion
2017-08-22

Countries

  • United States
  • Belgium
  • France
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161770 on ClinicalTrials.gov