- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259987
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
May 15, 2009 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands, 1105 AZ
- GSK Investigational Site
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Lima, Peru, 34
- GSK Investigational Site
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Lima
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San Isidro, Lima, Peru, Lima 27
- GSK Investigational Site
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California
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Los Angeles, California, United States, 90095
- GSK Investigational Site
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Michigan
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Ann Arbor, Michigan, United States, 48109
- GSK Investigational Site
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New York
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Buffalo, New York, United States, 14263
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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daily throughout the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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throughout the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
November 30, 2005
First Submitted That Met QC Criteria
November 30, 2005
First Posted (Estimate)
December 1, 2005
Study Record Updates
Last Update Posted (Estimate)
May 18, 2009
Last Update Submitted That Met QC Criteria
May 15, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGF102980
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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