Trials / Completed
CompletedNCT02157883
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 I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral Dose of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Pharmacokinetic sampling | Blood samples taken pre and post dosing with AZD9291+/- itraconazole |
| DRUG | AZD9291 | AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months. |
| DRUG | Itraconazole | Itraconazole tablets: 2x100mg bd, Part A days 6 to 19 only |
Timeline
- Start date
- 2014-11-06
- Primary completion
- 2015-04-03
- Completion
- 2023-05-17
- First posted
- 2014-06-06
- Last updated
- 2025-11-19
- Results posted
- 2016-04-14
Locations
16 sites across 6 countries: United States, Belgium, Netherlands, South Korea, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT02157883. Inclusion in this directory is not an endorsement.