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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
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
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
Actual Study Start Date : November 2003
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Neratinib Drug: neratinib

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Best Overall Response [ Time Frame: From first dose date to progression or last tumor assessment ]
    Best Overall Response by tumor type, evaluable population

  2. Duration of Response [ Time Frame: From start date of response to first PD ]
    Duration of response of responders (PR+) by Kaplan-Meier estimate

  3. 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.

  4. Objective Response Rate [ Time Frame: From first dose date to progression/death or last assessment ]
    Patients with PR or higher responses, evaluable population

  5. 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

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

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
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Ohio
The Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Tennessee
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Puma Biotechnology, Inc.
Study Director: Puma Biotechnology

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
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018
Last Verified: August 2017

Keywords provided by Puma Biotechnology, Inc.:

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