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NCT02157883 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT02157883: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02157883 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02157883, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy. Part A will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if they and the Investigator deem it appropriate, until such time as their disease progresses, the Investigator believes they are no longer deriving clinical benefit, or they stop taking AZD9291 for any other reason
Primary Outcome
Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration
Interventions
- DRUG Itraconazole
- DRUG AZD9291
- PROCEDURE Pharmacokinetic sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-11-06 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 1 |
What the finished NCT02157883 record still lists
NCT02157883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Itraconazole is the first listed.
NCT02157883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02157883 about?
NCT02157883 is a clinical study titled "Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)". This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy. Part A will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic (PK) parameter...
What is the current status of trial NCT02157883?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2014-11-06. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT02157883?
The interventions under investigation include: Itraconazole (DRUG), AZD9291 (DRUG), Pharmacokinetic sampling (PROCEDURE).
Who is sponsoring clinical trial NCT02157883?
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 NCT02157883's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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