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NCT02197247 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT02197247: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02197247 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02197247, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 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 rifampicin on the pharmacokinetic (PK) parameters of AZD9291 and metabolites AZ5104 and AZ7550 following multiple oral dosing of both rifampicin and 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 who complete Part A will be able to enter part B, and continue to receive AZD9291 80 mg once daily until: disease progression; they are no longer deriving clinical benefit; or any other reason.
Primary Outcome
Rate and extent of absorption of AZD9291 by assessment of maximum plasma concentration at steady state (Css,max). AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).
Interventions
- DRUG Rifampicin
- PROCEDURE Pharmacokinetic sampling - AZD9291
- DRUG AZD9291 tablet dosing
- PROCEDURE Pharmacokinetic sampling - AZ5140 and AZ7550
- PROCEDURE Pharmacokinetic sampling - rifampicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2014-12-04 |
| Est. Completion | 2021-05-26 |
| Phase | Phase 1 |
What the finished NCT02197247 record still lists
NCT02197247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 5 interventions - of which Rifampicin is the first listed.
NCT02197247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02197247 about?
NCT02197247 is a clinical study titled "Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, 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 NCT02197247?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2014-12-04. Estimated completion is 2021-05-26.
What interventions are being tested in trial NCT02197247?
The interventions under investigation include: Rifampicin (DRUG), Pharmacokinetic sampling - AZD9291 (PROCEDURE), AZD9291 tablet dosing (DRUG), Pharmacokinetic sampling - AZ5140 and AZ7550 (PROCEDURE), Pharmacokinetic sampling - rifampicin (PROCEDURE).
Who is sponsoring clinical trial NCT02197247?
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 NCT02197247's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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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