At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 273 enrolled
Drug / intervention
Lapatinib +1 moredrug
Likely dose
Lapatinib 250 mgfrom 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.
A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone in the Second Line Treatment of ErbB2 Amplified Advanced Gastric Cancer
In Brief
A Phase 3 clinical trial evaluating Lapatinib and Paclitaxel for Neoplasms, Gastrointestinal Tract. Completed, enrolled 273 participants across 17 sites in 4 countries.
Detailed Summary
EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Gastrointestinal Tract
CountriesChina, Japan, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2007
Enrollment StartJul 2007
Primary CompletionJan 2012
Study CompletionOct 2012
TodayJul 2026
First PostedJun 15, 2007
Enrollment StartJul 1, 2007
Primary CompletionJan 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.0 years ago
Interventions
Lapatinibdrug
6 pills at 250 mg each once daily
Paclitaxeldrug
Infusion at 80 mg/m2 weekly