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
Verified date | August 2014 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Bulgaria, Romania,
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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