Solid TumoursPhase 1NCT02161770
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
A Phase 1 study testing AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291 and Pharmacokinetic sampling - AZ5140 and AZ7550 in people with Solid Tumours, run by AstraZeneca at 19 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumours
- What is being tested?
- AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291 and Pharmacokinetic sampling - AZ5140 and AZ7550
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 22 Dec 2014to 22 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participation in another clinical study with an IP during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
- Treatment in the previous 3 months before dosing in this study with any drug known to have a well-defined potential for fulminant hepatotoxicity (eg, halothane and methotrexate).
- Treatment with any of the following: an EGFR TKI w/in 8 days or approximately 5x half-life, whichever is the longer, of the first dose of study treatment; Any cytotoxic chemotherapy, investigational agents or other anticancer drugs w/in 14 days of the first dose of study treatment; Major surgery (excluding placement of vascular access) w/in 4 weeks of the first dose; Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first dose of study treatment; Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior) (Appendix H). All patients in Part B and continued access must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known potent inducer/inhibitory effects on CYP3A4 (Appendix H).
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy.
- Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of the IP until final PK sample collection on Day 22.
- Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment.
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- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: ANCless than1.5x10.9/L; platelet count less than100x10.9/L; haemoglobinless than90 g/L; Creatinine greater than1.5 x institutional ULN concurrent with creatinine clearance less than50 mL/min (measured or calculated by Cockcroft-Gault formula); confirmation of creatinine clearance is only required when creatinine is greater than1.5 x institutional ULN.
- Any of the following cardiac criteria: Mean resting corrected QT interval corrected for heart rate using Fridericia's correction factor (QTcF) greater than470 msec obtained from 3 ECGs; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, PR interval greater than250 msec; Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval.
- Patients unable to swallow oral medication or patients with GI disorders or significant GI resection likely to interfere with the absorption of AZD9291.
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- Women who are breastfeeding.
- Patients with a known hypersensitivity to AZD9291 or any of its excipients. Patients with normal hepatic function should not have a history or presence of hepatic disease known to interfere with the absorption, distribution, metabolism or excretion of AZD9291.
- Patients with mild or moderate hepatic function should not enter if the following are fulfilled:
- Patients with hepatic encephalopathy within the last 4 weeks prior to Day 1.
- Fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period.
- Presence of acute liver disease caused by drug toxicity or by an infection.
- Severe portal hypertension or surgical porto-systemic shunts.
- Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
- Oesophageal variceal bleeding within the past 2 months.
- Anticoagulant therapy with warfarin or related coumadine.NOTE: Preferred format includes lists of inclusion and exclusion criteria
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
France6 sites
Research Site
Angers, Angers Cedex 9
Research Site
Marseille, 13915
Research Site
Pierre-Bénite, 69495
Research Site
Rennes, 35000
Research Site
Saint-Herblain, 44805
Research Site
Toulouse, 31059
United States5 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Cleveland, Ohio, 44106-4948
Research Site
Detroit, Michigan, 48202
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92123
Spain4 sites
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28046
Research Site
Madrid, 28050
About this study
Official title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 Following a Single Oral Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment
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
- Solid Tumours
- Being tested
- AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291, Pharmacokinetic sampling - AZ5140 and AZ7550
- Keywords
- oncology, cancer, neoplasm, anticancer drug, pharmacokinetics, area under curve, AZD9291, solid tumour, mild hepatic impairment, moderate hepatic impairment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9291 tablet dosingDrug
Part A - single 80mg oral dose AZD9291 (administered as 1 80mg tablet). Part B - 80mg oral dose AZD9291 od.
Pharmacokinetic sampling - AZD9291Procedure or surgery
Blood sampling to measure AZD9291 pharmacokinetic parameters.
Pharmacokinetic sampling - AZ5140 and AZ7550Procedure or surgery
Blood samples to measure the pharmacokinetic parameters of AZ5104 and AZ7550.
| Study group | Role | What they receive |
|---|---|---|
| Normal hepatic function | Other | Patients without a history or presence of hepatic disease Receives: Drug: AZD9291 tablet dosing; Procedure: Pharmacokinetic sampling - AZD9291; Procedure: Pharmacokinetic sampling - AZ5140 and AZ7550 |
| Mild hepatic impairment | Other | Patients defined by the Child-Pugh classification system to be Child-Pugh A Receives: Drug: AZD9291 tablet dosing; Procedure: Pharmacokinetic sampling - AZD9291; Procedure: Pharmacokinetic sampling - AZ5140 and AZ7550 |
| Moderate hepatic impairment | Other | Patients defined by the Child-Pugh classification system to be Child-Pugh B Receives: Drug: AZD9291 tablet dosing; Procedure: Pharmacokinetic sampling - AZD9291; Procedure: Pharmacokinetic sampling - AZ5140 and AZ7550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration (Cmax)
Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of maximum plasma AZD9291 concentration (Cmax).
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to infinity (AUC)
Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of area under the plasma concentration time curve from zero to infinity (AUC).
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Secondary outcomes (13)
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of AUC(0-t)
Rate and extent of absorption of AZD9291 by assessment of AUC from time zero to last quantifiable dose AUC(0-t)
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZ5104 and AZ7550 by assessment of Cmax
Assessment of the PK of AZ5104 and AZ7550 using maximum plasma concentration (Cmax).
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Assessment of the safety and tolerability of AZD9291
Safety data collected using: Assessment of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.0; Vital signs (blood pressure, pulse, temperature, height, weight); laboratory parameters (clinical chemistry, haematology, urinalysis); physical examination; and standard 12-lead electrocardiograms (ECGs)
Measured: Parts A and B, approximately seven months
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of tmax
Rate and extent of absorption of AZD9291, AZ5104, and AZ7550 by assessment of time to Cmax (tmax)
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of AUC(0-24)
Rate and extent of absorption of AZD9291, AZ5104, and AZ7550 by assessment of AUC from time zero to t=24, AUC(0-24)
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of AUC(0-72)
Rate and extent of absorption of AZD9291, AZ5104, and AZ7550 by assessment of AUC from time zero to t=72, AUC(0-72)
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of AUC(0-168)
Rate and extent of absorption of AZD9291, AZ5104, and AZ7550 by assessment of AUC from time zero to t=168, AUC(0-168).
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of λz
Rate and extent of absorption of AZD9291, AZ5104, and AZ7550 by assessment of terminal rate constant (λz).
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of t½
Rate and extent of absorption of AZD9291, AZ5104, and AZ7550 by assessment of the terminal half-life (t1/2).
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of CL(R)
Rate and extent of absorption of AZD9291, AZ5104, and AZ7550 by assessment of renal clearance (CL(R).
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291 by assessment of CL/F
Rate and extent of absorption of AZD9291 by assessment of the apparent clearance following oral administration (CL/F)
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291 by assessment of Vz/F
Rate and extent of absorption of AZD9291 by assessment of the apparent volume of distribution (Vz/F)
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZ5104 and AZ7550 by assessment of AUC
Assessment of the PK of AZ5104 and AZ7550 using area under the plasma concentration curve from zero extrapolated to infinity (AUC).
Measured: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study start22 Dec 2014
- Primary completion16 May 2017
- Study completion22 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuri Rukazenkov, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161770
- Sponsor's protocol ID
- D5160C00008
- Other IDs
- 2014-001515-39, 2014
- Status last verified
- Mar 2019
- First submitted
- 29 May 2014
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Grande E, Harvey RD, You B, Batlle JF, Galbraith H, Sarantopoulos J, Ramalingam SS, Mann H, So K, Johnson M, Vishwanathan K. Pharmacokinetic Study of Osimertinib in Cancer Patients with Mild or Moderate Hepatic Impairment. J Pharmacol Exp Ther. 2019 May;369(2):291-299. doi: 10.1124/jpet.118.255919. Epub 2019 Mar 14.
PubMed 30872388
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 Following a Single Oral Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment
- ClinicalTrials.gov ID
- NCT02161770
- Acronym / sponsor ID
- D5160C00008
- Conditions
- Solid Tumours
- Keywords
- oncology, cancer, neoplasm, anticancer drug, pharmacokinetics, area under curve, AZD9291, solid tumour, mild hepatic impairment, moderate hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2014 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal hepatic function | Other | Drug: AZD9291 tablet dosing, Procedure: Pharmacokinetic sampling - AZD9291, Procedure: Pharmacokinetic sampling - AZ5140 and AZ7550Patients without a history or presence of hepatic disease |
| Mild hepatic impairment | Other | Drug: AZD9291 tablet dosing, Procedure: Pharmacokinetic sampling - AZD9291, Procedure: Pharmacokinetic sampling - AZ5140 and AZ7550Patients defined by the Child-Pugh classification system to be Child-Pugh A |
| Moderate hepatic impairment | Other | Drug: AZD9291 tablet dosing, Procedure: Pharmacokinetic sampling - AZD9291, Procedure: Pharmacokinetic sampling - AZ5140 and AZ7550Patients defined by the Child-Pugh classification system to be Child-Pugh B |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Participation in another clinical study with an IP during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
- Treatment in the previous 3 months before dosing in this study with any drug known to have a well-defined potential for fulminant hepatotoxicity (eg, halothane and methotrexate).
- Treatment with any of the following: an EGFR TKI w/in 8 days or approximately 5x half-life, whichever is the longer, of the first dose of study treatment; Any cytotoxic chemotherapy, investigational agents or other anticancer drugs w/in 14 days of the first dose of study treatment; Major surgery (excluding placement of vascular access) w/in 4 weeks of the first dose; Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first dose of study treatment; Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior) (Appendix H). All patients in Part B and continued access must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known potent inducer/inhibitory effects on CYP3A4 (Appendix H).
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy.
- Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of the IP until final PK sample collection on Day 22.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9291 tablet dosingPart A - single 80mg oral dose AZD9291 (administered as 1 80mg tablet). Part B - 80mg oral dose AZD9291 od. | Drug | Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic function |
| Pharmacokinetic sampling - AZD9291Blood sampling to measure AZD9291 pharmacokinetic parameters. | Procedure or surgery | Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic function |
| Pharmacokinetic sampling - AZ5140 and AZ7550Blood samples to measure the pharmacokinetic parameters of AZ5104 and AZ7550. | Procedure or surgery | Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic function |
Primary outcome
Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration (Cmax)
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of maximum plasma AZD9291 concentration (Cmax).
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to infinity (AUC)
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of area under the plasma concentration time curve from zero to infinity (AUC).
13 secondary outcomes
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of AUC(0-t)
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZ5104 and AZ7550 by assessment of Cmax
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Assessment of the safety and tolerability of AZD9291
Time frame: Parts A and B, approximately seven months
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of tmax
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of AUC(0-24)
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of AUC(0-72)
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of AUC(0-168)
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of λz
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of t½
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291, AZ5104, and AZ7550 by assessment of CL(R)
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291 by assessment of CL/F
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZD9291 by assessment of Vz/F
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Pharmacokinetics of AZ5104 and AZ7550 by assessment of AUC
Time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Derived from this study: PubMed 30872388Grande E, Harvey RD, You B, Batlle JF, Galbraith H, Sarantopoulos J, Ramalingam SS, Mann H, So K, Johnson M, Vishwanathan K. Pharmacokinetic Study of Osimertinib in Cancer Patients with Mild or Moderate Hepatic Impairment. J Pharmacol Exp Ther. 2019 May;369(2):291-299. doi: 10.1124/jpet.118.255919. Epub 2019 Mar 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuri Rukazenkov study chair
AstraZeneca
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291 and Pharmacokinetic sampling - AZ5140 and AZ7550 in people with Solid Tumours, run by AstraZeneca at 19 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, United States, Spain, Belgium, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration (Cmax) (time frame: Blood samples are collected at the following timepoints post AZD9291 dose on Day 1: pre-dose, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.