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NCT02161770 · ClinicalTrials.gov registry record · Phase 1
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, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02161770: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02161770 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02161770, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
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.
Primary Outcome
Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of maximum plasma AZD9291 concentration (Cmax).
Interventions
- PROCEDURE Pharmacokinetic sampling - AZD9291
- DRUG AZD9291 tablet dosing
- PROCEDURE Pharmacokinetic sampling - AZ5140 and AZ7550
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-12-22 |
| Est. Completion | 2017-08-22 |
| Phase | Phase 1 |
What the finished NCT02161770 record still lists
NCT02161770 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Pharmacokinetic sampling - AZD9291 is the first listed.
NCT02161770 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02161770 about?
NCT02161770 is a clinical study titled "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". 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 ...
What is the current status of trial NCT02161770?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-12-22. Estimated completion is 2017-08-22.
What interventions are being tested in trial NCT02161770?
The interventions under investigation include: Pharmacokinetic sampling - AZD9291 (PROCEDURE), AZD9291 tablet dosing (DRUG), Pharmacokinetic sampling - AZ5140 and AZ7550 (PROCEDURE).
Who is sponsoring clinical trial NCT02161770?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02161770's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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