Status:
COMPLETED
Study Evaluating HKI-272 in Tumors
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272. In addition, this study will examine the effects of the study drug on...
Eligibility Criteria
Inclusion
- Her2/neu or Her1/EGFR positive cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Exclusion
- Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m\^2
- Patients with significant cardiac risk factors
- Active central nervous system metastasis
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00146172
Start Date
November 1 2003
End Date
January 1 2007
Last Update
September 17 2018
Active Locations (5)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
The Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio, United States, 44195