Study Evaluating HKI-272 in Tumors

Completed · Phase 1

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT00146172

Run by

Puma Biotechnology, Inc.

People needed

73

Starts

2003-11-01

Expected to finish

2007-01-01

Last updated by the study team

2018-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The Cleveland Clinic Foundation Taussig Cancer Center — Cleveland, Ohio, United States
• The Sarah Cannon Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.