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AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372788
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : August 13, 2014
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as long as patients receive clinical benefit.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: AZD6244 Drug: Pemetrexed Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Drug: Pemetrexed
Other Name: Alimta®

Experimental: 2
Drug: AZD6244
oral vial
Other Name: ARRY-142886

Primary Outcome Measures :
  1. Assess tumor growth [ Time Frame: assessed every 12 weeks ]

Secondary Outcome Measures :
  1. Assess safety and tolerability of AZD6244 [ Time Frame: assessed at each visit ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372788

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United States, California
Research Site
Los Angeles, California, United States
United States, Michigan
Research Site
Ann Arbor, Michigan, United States
United States, New York
Research Site
New York, New York, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Cluj-Napoca, Romania
Sponsors and Collaborators
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Study Director: Emerging Oncology Medical Science Director, MD AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca Identifier: NCT00372788    
Other Study ID Numbers: D1532C00012
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by AstraZeneca:
Advanced Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors