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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Pemetrexed

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type DRUG

oral

2

AZD6244

Group Type EXPERIMENTAL

AZD6244

Intervention Type DRUG

oral vial

Interventions

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AZD6244

oral vial

Intervention Type DRUG

Pemetrexed

oral

Intervention Type DRUG

Other Intervention Names

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ARRY-142886 Alimta®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No