Study Evaluating HKI-272 in Tumors
The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Adverse events will be assessed on a continuous basis, physical exam, ECG, and ECOG performance status will be done at the beginning of every 1 month cycle. Laboratory evaluations will be performed approximately every 14 days.
- Tumor assessment at screening and at the end of cycles 2, 4, and 6. Pharmacokinetics blood samples throughout study, including 8 hour PK day (sample every hour) on study day 14. Pharmacodynamic blood sample at screening and day 14.
|Study Start Date:||November 2003|
|Study Completion Date:||January 2007|
|United States, Florida|
|Tampa, Florida, United States, 33612|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Boston, Massachusetts, United States, 02215|
|Boston, Massachusetts, United States, 02114|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|