Adenocarcinoma
Conditions
Keywords
relapsed adenocarcinoma, esophagus, tumors, GE junction, cancer, lapatinib, gastric cardia
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Netherlands, Peru, United States
Outcome results
None listed