Status:
COMPLETED
AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients
Lead Sponsor:
AstraZeneca
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small ce...
Detailed Description
The primary objective of this study was to assess the efficacy in terms of overall survival (OS) of AZD6244 in combination with docetaxel, compared with docetaxel alone, in second-line patients with K...
Eligibility Criteria
Inclusion
- Locally advanced or metastatic non small cell lung cancer (IIIB-IV)
- Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
- Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21).
Exclusion
- Received \>1 prior anti-cancer therapy for advanced or metastatic non small cell lung cancer (excluding radiotherapy)
- Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable)
- Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
- Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month
Key Trial Info
Start Date :
April 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2016
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00890825
Start Date
April 20 2009
End Date
November 2 2016
Last Update
June 20 2018
Active Locations (63)
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1
Research Site
Los Angeles, California, United States, 90095
2
Research Site
Aurora, Colorado, United States, 80045
3
Research Site
Boston, Massachusetts, United States, 02115
4
Research Site
Columbus, Ohio, United States, 43210