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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lapatinib (GW572016) oral tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No