CompletedPhase 2NCT00890825

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

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.

Checked against the public recordLast updated Jun 20, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations63
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
AstraZeneca
Interventions being studied
Drug: AZD6244; Drug: docetaxel; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Criteria: * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteLos Angeles, California
  • Research SiteAurora, Colorado
  • Research SiteBoston, Massachusetts
  • Research SiteColumbus, Ohio
  • Research SiteBrussels
  • Research SiteCharleroi
  • Research SiteEdegem
  • Research SiteLeuven
  • Research SiteLiège
  • Research SiteLiège
  • Research SiteBelo Horizonte
  • Research SiteIjuí

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 20, 2018. Always confirm current availability with the study team.

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