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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02161770
The ClinicalTrials.gov registry entry for NCT02161770 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pharmacokinetic sampling - AZD9291 is the first listed.
NCT02161770 reports 0 study locations.
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.
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