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A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-Small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-Small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen


Inclusion Criteria:



- Diagnosed with non-small cell lung cancer

- Previously received one or two chemotherapeutic treatments

Exclusion Criteria:

- Previous therapy with MEK inhibitor or pemetrexed

- Any recent surgery, unhealed surgical incision or severe condition such as
uncontrolled cardiac disease or chronic gastrointestinal diseases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess tumor growth

Outcome Time Frame:

assessed every 12 weeks

Safety Issue:

No

Principal Investigator

Emerging Oncology Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D1532C00012

NCT ID:

NCT00372788

Start Date:

August 2006

Completion Date:

December 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Advanced Non-Small Cell Lung Cancer
  • AZD6244
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Research Site Anaheim, California  
Research Site Battle Kreek, Michigan  
Research Site Albany, New York  
Research Site Chattanooga, Tennessee