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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259987
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : May 18, 2009
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Drug: Lapatinib (GW572016) oral tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259987

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United States, California
GSK Investigational Site
Los Angeles, California, United States, 90095
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14263
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
San Isidro, Lima, Peru, Lima 27
GSK Investigational Site
Lima, Peru, 34
Sponsors and Collaborators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
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Responsible Party: Study Director, GSK Identifier: NCT00259987    
Obsolete Identifiers: NCT00345995
Other Study ID Numbers: EGF102980
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009
Keywords provided by GlaxoSmithKline:
relapsed adenocarcinoma
GE junction
gastric cardia
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action