Phase I Study of Lapatinib in Combination With Trastuzumab
Overview
- Phase
- Phase 1
- Intervention
- GW572016 oral tablets
- Conditions
- Neoplasms, Breast
- Sponsor
- GlaxoSmithKline
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
GW572016 in combination with trastuzumab
Lapatinib: A specified dose of lapatinib will be orally taken once daily, at least one hour before or one hour after the morning meal. Lapatinib should be taken at the same time of day wherever possible. The starting dose of lapatinib should be 750 mg/day, which will be increased to 1000 mg/day (dose escalation group) according to the dose escalation criteria. Trastuzumab: Trastuzumab (4 mg/kg/day in the first week and 2 mg/kg/day for the 2nd and subsequent weeks) will be administered by intravenous infusion over at least 90 minutes immediately after administration of lapatinib. The fifth (Day 36) and subsequent doses may be administered up to 3 days after the scheduled date. In this case, however, the all following doses should be administered at one-week intervals.
Intervention: GW572016 oral tablets
Outcomes
Primary Outcomes
Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly
Time Frame: 6 Months
To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan.
Secondary Outcomes
- Clinical benefit Time to tumor response Length of response Time to progression of cancer 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue(6 Months)