CompletedPhase 2

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

United States, Netherlands, Peru24 participantsStarted 2005-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)

Timeframe: daily throughout the study

Trial details

NCT IDNCT00259987

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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