Status:
COMPLETED
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
Lead Sponsor:
GlaxoSmithKline
Conditions:
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00259987
Start Date
November 1 2005
End Date
May 1 2007
Last Update
May 18 2009
Active Locations (6)
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1
GSK Investigational Site
Los Angeles, California, United States, 90095
2
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
3
GSK Investigational Site
Buffalo, New York, United States, 14263
4
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ