At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 68 enrolled
Drug / intervention
Lapatinib and Capecitabinedrug
Likely dose
Lapatinib and Capecitabine 1250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory, Phase II Trial to Determine the Association of Lapatinib Induced Fluoropyrimidine Gene Changes With Efficacy Parameters of Lapatinib and Capecitabine in First Line Gastric Cancer
In Brief
A Phase 2 clinical trial evaluating Lapatinib and Capecitabine for Neoplasms, Gastrointestinal Tract. Completed, enrolled 68 participants across 22 sites in 6 countries.
Detailed Summary
The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Gastrointestinal Tract
CountriesCanada, Mexico, Russia, South Korea, Taiwan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2007
Enrollment StartMar 2008
Primary CompletionApr 2011
Study CompletionJan 2015
TodayJul 2026
First PostedSep 10, 2007
Enrollment StartMar 1, 2008
Primary CompletionApr 1, 2011
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.8 years ago
Interventions
Lapatinib and Capecitabinedrug
oral lapatinib (1250mg) administered as a monotherapy run-in followed by its combination with capecitabine