Status:
COMPLETED
GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
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 (...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with confirmed breast cancer who have received prior trastuzumab.
- Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
- Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
- Exclusion criteria:
- Patients with certain heart problems.
Exclusion
Key Trial Info
Start Date :
April 6 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00371488
Start Date
April 6 2006
End Date
December 10 2007
Last Update
August 31 2018
Active Locations (2)
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1
GSK Investigational Site
Saitama, Japan, 350-1298
2
GSK Investigational Site
Tokyo, Japan, 135-8550