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Study Evaluating HKI-272 in Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00146172
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasms Drug: neratinib Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2003
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Neratinib
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: neratinib

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146172

United States, Florida
Tampa, Florida, United States, 33612
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02215
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
Puma Biotechnology, Inc.
Study Director: Puma Biotechnology
More Information

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00146172     History of Changes
Other Study ID Numbers: 3144A1-102
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by Puma Biotechnology, Inc.:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases