Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
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
1 other identifier
interventional
24
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2005
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 30, 2005
CompletedFirst Posted
Study publicly available on registry
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMay 18, 2009
May 1, 2009
November 30, 2005
May 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
daily throughout the study
Secondary Outcomes (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.
throughout the study
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (6)
GSK Investigational Site
Los Angeles, California, 90095, United States
GSK Investigational Site
Ann Arbor, Michigan, 48109, United States
GSK Investigational Site
Buffalo, New York, 14263, United States
GSK Investigational Site
Amsterdam, 1105 AZ, Netherlands
GSK Investigational Site
San Isidro, Lima region, Lima 27, Peru
GSK Investigational Site
Lima, 34, Peru
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 30, 2005
First Posted
December 1, 2005
Study Start
November 1, 2005
Study Completion
May 1, 2007
Last Updated
May 18, 2009
Record last verified: 2009-05