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NCT00372788 Clinical Trial

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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00372788
Other study ID # D1532C00012
Secondary ID
Status Completed
Phase Phase 2
First received September 5, 2006
Last updated August 12, 2014
Start date August 2006
Est. completion date December 2008

Study information
Verified date August 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date December 2008
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• AZD6244
oral vial
• Pemetrexed
oral

Locations
Country Name City State
Bulgaria Research Site Plovdiv
Bulgaria Research Site Sofia
Bulgaria Research Site Varna
Romania Research Site Cluj-Napoca
United States Research Site Ann Arbor Michigan
United States Research Site Los Angeles California
United States Research Site Nashville Tennessee
United States Research Site New York New York

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Bulgaria,  Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess tumor growth assessed every 12 weeks No
Secondary Assess safety and tolerability of AZD6244 assessed at each visit Yes
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