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NCT02197234 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT02197234: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02197234 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02197234, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent. Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of simvastatin and simvastatin acid, following multiple oral dosing of AZD9291 in a fasted state. Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will provide for additional safety data collection. All patients from Part A who completed treatment may continue to receive AZD9291 80 mg once daily until: disease progression; they are no longer deriving clinical benefit; or any other reason.
Primary Outcome
Pharmacokinetics of simvastatin by assessment of maximum plasma simvastatin concentration
Interventions
- DRUG Simvastatin
- PROCEDURE Pharmacokinetic sampling - AZD9291
- DRUG AZD9291 tablet dosing
- PROCEDURE Pharmacokinetic sampling - AZ5140 and AZ7550
- PROCEDURE Pharmacokinetic sampling - simvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-12-22 |
| Est. Completion | 2024-06-03 |
| Phase | Phase 1 |
What the finished NCT02197234 record still lists
NCT02197234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 5 interventions - of which Simvastatin is the first listed.
NCT02197234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02197234 about?
NCT02197234 is a clinical study titled "Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC". This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent. Part ...
What is the current status of trial NCT02197234?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2014-12-22. Estimated completion is 2024-06-03.
What interventions are being tested in trial NCT02197234?
The interventions under investigation include: Simvastatin (DRUG), Pharmacokinetic sampling - AZD9291 (PROCEDURE), AZD9291 tablet dosing (DRUG), Pharmacokinetic sampling - AZ5140 and AZ7550 (PROCEDURE), Pharmacokinetic sampling - simvastatin (PROCEDURE).
Who is sponsoring clinical trial NCT02197234?
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 NCT02197234's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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