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Study Evaluating HKI-272 in Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146172
First Posted: September 5, 2005
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
September 2, 2005
September 5, 2005
October 12, 2017
November 2003
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00146172 on ClinicalTrials.gov Archive Site
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.
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.
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
Drug: neratinib
HKI-272
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
January 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00146172
3144A1-102
Not Provided
Not Provided
Not Provided
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Study Director: Puma Biotechnology
Puma Biotechnology, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP