Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT00486954
- Phase
- PHASE3
- Status
- Completed
Conditions
- Neoplasms, Gastrointestinal Tract
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lapatinib — DRUG6 pills at 250 mg each once daily
- Paclitaxel — DRUGInfusion at 80 mg/m2 weekly
Study Details
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.
Key Dates
- First listed
- Jun 15, 2007
- Start date
- Jul 31, 2007
- Status verified
- Jan 2013
- Primary completion
- Jan 31, 2012
- Completion
- Oct 31, 2012
Study Design
- Enrollment
- 273 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Paclitaxel plus Lapatinib6 pills of lapatinib at 250 mg each once daily and infusion of paclitaxel at 80 mglm2 weekly
- Active Comparator: Paclitaxel aloneInfusion of paclitaxel at 80 mglm2 weekly
Primary Outcome Measure
Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study [ Time Frame: 28 days ]