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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

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ClinicalTrials.gov Identifier: NCT00372788
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

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

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Pemetrexed
Drug: Pemetrexed
oral
Other Name: Alimta®
Experimental: 2
AZD6244
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00372788


Locations
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
Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Romania
Research Site
Cluj-Napoca, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Emerging Oncology Medical Science Director, MD AstraZeneca

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00372788     History of Changes
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:
NSCLC
Advanced Non-Small Cell Lung Cancer
AZD6244

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors