Trials / Completed
CompletedNCT00146172
Study Evaluating HKI-272 in Tumors
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Puma Biotechnology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 your tumor, and how your body uses and eliminates HKI-272.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | neratinib | HKI-272 |
Timeline
- Start date
- 2003-11-01
- Primary completion
- 2007-01-01
- Completion
- 2007-01-01
- First posted
- 2005-09-05
- Last updated
- 2018-09-17
- Results posted
- 2018-02-13
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00146172. Inclusion in this directory is not an endorsement.