Study Evaluating HKI-272 in Tumors - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00146172

Purpose

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.

Condition	Intervention	Phase
Breast Neoplasms	Drug: HKI-272	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: HKI-272

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Tumor assessment at screening and at the end of cycles 2, 4, and 6. Pharmacokinetics blood samples throughout study, inlcuding 8 hour PK day (sample every hour) on study day 14. Pharmacodynamic blood sample at screening and day 14.

Estimated Enrollment:	88
Study Start Date:	November 2003
Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Her2/neu or Her1/EGFR positive cancer
ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
Measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors)

Exclusion Criteria:

Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m2
Patients with significant cardiac risk factors
Active central nervous system metastasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146172

Locations

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

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3144A1-102
Study First Received:	September 2, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00146172 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Tumors

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 04, 2009