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Study Evaluating HKI-272 in Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00146172
First received: September 2, 2005
Last updated: May 10, 2012
Last verified: May 2012

September 2, 2005
May 10, 2012
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00146172
3144A1-102
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