Study Evaluating HKI-272 in Tumors

Status:	Completed
Conditions:	Breast Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	9/19/2018
Start Date:	November 2003
End Date:	January 2007

An Ascending Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Subjects With HER-2/NEU or HER-1/EGFR-Positive Tumors

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 your tumor, and how your body uses and eliminates HKI-272.

Inclusion Criteria:

- 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 Criteria:

- 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

We found this trial at

sites

Cleveland Clinic Foundation, Taussig Cancer Center

Cleveland, Ohio 44195

from

Cleveland, OH