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

May 15, 2009 updated by: GlaxoSmithKline

A Phase II, Open-Label Study Evaluating Clinical Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of Lapatinib (GW572016) in Patients With Relapsed Adenocarcinoma of the Esophagus, Including Tumors of the Gastroesophageal Junction and Gastric Cardia

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.

Study Overview

Status

Completed

Conditions

Adenocarcinoma

Intervention / Treatment

Drug: Lapatinib (GW572016) oral tablets

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - GSK Investigational Site
Peru
- - Lima, Peru, 34
    - GSK Investigational Site
- Lima
  - San Isidro, Lima, Peru, Lima 27
    - GSK Investigational Site
United States
- California
  - Los Angeles, California, United States, 90095
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - GSK Investigational Site
- New York
  - Buffalo, New York, United States, 14263
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

Has a histologically confirmed adenocarcinoma of the esophagus.
GE (gastroesophageal) junction or gastric cardia.
Must be of non-child-bearing potential or is of child-bearing potential.
Have a negative serum pregnancy test and agree to an approved form of birth control.
Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or equal to 2.
Have a life expectancy of at least 12 weeks.
Have provided written informed consent.
Investigator considers patient to be fit for study from lab test results and interview.

Exclusion criteria:

Pregnant or lactating female.
Prior resection of the small bowel.
Received major surgery.
Received prior radiation therapy to the mediastinum or abdomen.
Has a known immediate or delayed hypersensitivity reaction.
Idiosyncrasy to drugs chemically related to the study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: throughout the study	throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria