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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Pemetrexed; Drug: AZD6244

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372788

D1532C00012

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

1

Active Comparator group

Description:

Pemetrexed

Treatment:

Drug: Pemetrexed

2

Experimental group

Description:

AZD6244

Treatment:

Drug: AZD6244