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

Completed · Phase 2

Conditions studied: Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00259987

Run by

GlaxoSmithKline

People needed

24

Starts

2005-11-01

Expected to finish

2007-05-01

Last updated by the study team

2009-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• GSK Investigational Site — San Isidro, Lima region, Peru
• GSK Investigational Site — Lima, Peru

Full record on ClinicalTrials.gov

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