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A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic Non Small Cell Lung Cancer (Stage IIIB- IV)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic Non Small Cell Lung Cancer (Stage IIIB- IV)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To assess the efficacy in terms of Overall Survival (OS) of AZD6244 in combination with docetaxel compared with docetaxel alone, in 2nd line patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer

Outcome Time Frame:

Time Frame: Overall survival calculated as the interval from date of randomisation to date of patient death (any cause). Patients who have not died at final analysis, or who withdraw consent, will be censored at last date they were known to be alive.

Safety Issue:

No

Principal Investigator

Dr Pasi Janne

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute, Boston, USA

Authority:

United States: Food and Drug Administration

Study ID:

D1532C00016

NCT ID:

NCT00890825

Start Date:

April 2009

Completion Date:

June 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Non small cell lung cancer (NSCLC)
  • KRAS mutation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteBeverly, Massachusetts  
Research SiteAkron, Ohio