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

This study has been completed.

First Received: November 30, 2005 Last Updated: October 9, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00259987

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 II

MedlinePlus related topics: Cancer

Drug Information available for: Lapatinib Lapatinib Ditosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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

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

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
Lima, Peru, 34
Peru, Lima
GSK Investigational Site
San Isidro, Lima, Peru, Lima 27

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	EGF102980
Study First Received:	November 30, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00259987 History of Changes
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

Study placed in the following topic categories:

Lapatinib
Adenocarcinoma
Protein Kinase Inhibitors
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

Lapatinib
Adenocarcinoma
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009