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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 41 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02197247
The ClinicalTrials.gov registry entry for NCT02197247 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 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 5 interventions - of which Rifampicin is the first listed.
NCT02197247 reports 0 study locations.
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.
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