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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 22, 2014

Primary Completion Date

May 16, 2017

Study Completion Date

August 22, 2017

Conditions
Solid Tumours
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.

Trial Locations (19)

1200

Research Site, Woluwé-St-Lambert

9000

Research Site, Ghent

13915

Research Site, Marseille

28034

Research Site, Madrid

28040

Research Site, Madrid

28046

Research Site, Madrid

28050

Research Site, Madrid

30322

Research Site, Atlanta

31059

Research Site, Toulouse

35000

Research Site, Rennes

44805

Research Site, Saint-Herblain

48202

Research Site, Detroit

69495

Research Site, Pierre-Bénite

78229

Research Site, San Antonio

92123

Research Site, San Diego

44106-4948

Research Site, Cleveland

Angers Cedex 9

Research Site, Angers

05505

Research Site, Seoul

NE7 7DN

Research Site, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY