Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
Phase 2
Completed
- Conditions
- Adenocarcinoma
- Registration Number
- NCT00259987
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie lapatinib's efficacy in relapsed esophageal adenocarcinoma?
How does lapatinib compare to standard-of-care therapies for gastroesophageal junction adenocarcinoma?
Which biomarkers correlate with response to lapatinib in HER2-positive gastric cardia tumors?
What are the key adverse events associated with lapatinib 1500 mg daily dosing in advanced adenocarcinoma?
How do EGFR and HER2 tyrosine kinase inhibitors like lapatinib influence esophageal cancer treatment paradigms?
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇪Lima, Peru
GSK Investigational Site🇵🇪Lima, Peru