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. Identifier: NCT00146172
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

September 2, 2005
September 5, 2005
August 10, 2017
February 13, 2018
February 13, 2018
November 2003
January 2007   (Final data collection date for primary outcome measure)
Number of Subjects With Dose Limiting Toxicities (DLT) [ Time Frame: From first dose date to day 14 ]
A dose limiting toxicity (DLT) is defined as any neratinib-related nonhematologic grade 3 or any grade 4 AE according to the NCI common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.
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.
Complete list of historical versions of study NCT00146172 on Archive Site
  • Best Overall Response [ Time Frame: From first dose date to progression or last tumor assessment ]
    Best Overall Response by tumor type, evaluable population
  • Duration of Response [ Time Frame: From start date of response to first PD ]
    Duration of response of responders (PR+) by Kaplan-Meier estimate
  • Progression Free Survival [ Time Frame: From first dose date to progression or death ]
    Kaplan-Meier estimate of time to progression/death from first dose, evaluable population.
  • Objective Response Rate [ Time Frame: From first dose date to progression/death or last assessment ]
    Patients with PR or higher responses, evaluable population
  • Clinical Benefit Rate [ Time Frame: From first dose date to progression/death or last assessment ]
    Patients with PR or higher responses or SD>=24 weeks, evaluable population
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
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
Drug: neratinib
Experimental: Neratinib
Intervention: Drug: neratinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2007
January 2007   (Final data collection date for primary outcome measure)

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, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Study Director: Puma Biotechnology
Puma Biotechnology, Inc.
August 2017

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