Back to resultsEffects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
Primary Purpose
Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lapatinib (GW572016) oral tablets
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma focused on measuring relapsed adenocarcinoma, esophagus, tumors, GE junction, cancer, lapatinib, gastric cardia
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00259987
Brief Title
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma
Keywords
relapsed adenocarcinoma, esophagus, tumors, GE junction, cancer, lapatinib, gastric cardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lapatinib (GW572016) oral tablets
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
GSK Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
GSK Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
San Isidro
State/Province
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
34
Country
Peru
12. IPD Sharing Statement
Learn more about this trial
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
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