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

GlaxoSmithKline24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adenocarcinoma

Interventions

Lapatinib (GW572016) oral tabletsDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Ann Arbor, Michigan, United States

GSK Investigational Site

Buffalo, New York, United States

GSK Investigational Site

Amsterdam, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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