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

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Pemetrexed; Drug: AZD6244

• Registration Number: NCT00372788
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-05
• Study First Posted: 2006-09-07
• Primary Completion: 2007-07
• Study Completion: 2008-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pemetrexed	Pemetrexed
2	AZD6244	AZD6244

Primary Outcome Measures

Name	Time	Method
Assess tumor growth	assessed every 12 weeks

Secondary Outcome Measures

Name	Time	Method
Assess safety and tolerability of AZD6244	assessed at each visit

Trial Locations

Locations (1)

Research Site; 🇷🇴 Cluj-Napoca, Romania