Trials / Completed
CompletedNCT01802632
AZD9291 First Time In Patients Ascending Dose Study
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 603 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
Summary
This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.
Detailed description
A Phase I/II, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of AZD9291 in Patients with Advanced Non Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent (AURA)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD9291 | Starting dose 20 mg, administered once daily. If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined |
Timeline
- Start date
- 2013-03-04
- Primary completion
- 2015-05-01
- Completion
- 2023-12-13
- First posted
- 2013-03-01
- Last updated
- 2024-01-18
- Results posted
- 2016-10-06
Locations
45 sites across 10 countries: United States, Australia, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT01802632. Inclusion in this directory is not an endorsement.