AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Non Small Cell Lung Cancer

In brief

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 cell lung cancer.

Key facts

Study ID

NCT00890825

Run by

AstraZeneca

People needed

88

Starts

2009-04-20

Expected to finish

2016-11-02

Last updated by the study team

2018-06-20

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Research Site — Aurora, Colorado, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Brussels, Belgium
• Research Site — Charleroi, Belgium
• Research Site — Edegem, Belgium
• Research Site — Leuven, Belgium
• Research Site — Liège, Belgium
• Research Site — Liège, Belgium
• Research Site — Belo Horizonte, Brazil
• Research Site — Ijuí, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Rio de Janeiro, Brazil
• Research Site — Santo André, Brazil
• Research Site — São Paulo, Brazil
• Research Site — São Paulo, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Plovdiv, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Varna, Bulgaria
• Research Site — Oshawa, Ontario, Canada
• Research Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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