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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00259987
First received: November 30, 2005
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Adenocarcinoma
Drug: Lapatinib (GW572016) oral tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 24
Study Start Date: November 2005
Study Completion Date: May 2007
Intervention Details:
    Drug: Lapatinib (GW572016) oral tablets
    Other Name: Lapatinib (GW572016) oral tablets
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259987

Locations
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
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
Peru
GSK Investigational Site
San Isidro, Lima, Peru, Lima 27
GSK Investigational Site
Lima, Peru, 34
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00259987     History of Changes
Obsolete Identifiers: NCT00345995
Other Study ID Numbers: EGF102980
Study First Received: November 30, 2005
Last Updated: May 15, 2009
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by GlaxoSmithKline:
relapsed adenocarcinoma
esophagus
tumors
GE junction
cancer
lapatinib
gastric cardia

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Lapatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014