Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus

Phase 2

Completed

• Conditions: Adenocarcinoma

• Registration Number: NCT00259987
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-30
• Study First Submitted QC: 2005-11-30
• Study First Posted: 2005-12-01
• Study Completion: 2007-05
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)	daily throughout the study

Secondary Outcome Measures

Name	Time	Method
Safety and clinical benefit of lapatinib therapy, progression-free survival, and response duration in the two dose levels combined as well as for the two doses separately.	throughout the study

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇪 Lima, Peru