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A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid 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: NCT00397046
Recruitment Status : Completed
First Posted : November 8, 2006
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the tolerability and safety of HKI-272, and to determine the maximum dose that can safety be given. The secondary purpose of this study is to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is effective for the treatment of advanced solid tumors.

Condition or disease Intervention/treatment Phase
Tumors Drug: neratinib Phase 1

Detailed Description:
This is a phase 1 open-label sequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. Each subject will participate in only 1 dose group and will receive a single dose of test article, followed by a 1-week observation period, and then will receive the test article administered once-daily by mouth in cycles consisting of 28 days. Subjects will be enrolled in groups of 3 to 6. Adverse events and dose-limiting toxicities will be assessed from the first single dose.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Ascending and Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-272 Administered Orally to Japanese Subjects With Advanced Solid Tumors
Study Start Date : November 2006
Primary Completion Date : March 2009
Study Completion Date : March 2009

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. Safety will be assessed through adverse event evaluation, physical exams, and laboratory evaluations. Efficacy will be assessed through radiographic evaluation. [ Time Frame: 16 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  1. Diagnosis of metastatic or advanced cancer that has failed standard effective therapy
  2. Life expectancy of at least 12 weeks and adequate performance status
  3. Adequate bone marrow, kidney and liver function
  4. Willingness of male and female subjects who are not surgically sterile or post-menopausal to use adequate methods of birth control

Exclusion Criteria

  1. Any anticancer chemotherapy, radiotherapy immunotherapy or investigational agents within 4 weeks of first dose of HKI-272
  2. Inadequate cardiac function
  3. Surgery within 2 weeks of first dose of HKI-272
  4. Active central nervous system metastases (i.e., symptomatic, required use of corticosteroids and/or progressive growth)
  5. Significant gastrointestinal disorder with diarrhea as a major symptom
  6. Pregnant or breast feeding women
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): NCT00397046

Sunto-gun, Shizuoka, Japan, 1411-8777
Koto-ku, Tokyo, Japan, 135-8550
Sponsors and Collaborators
Puma Biotechnology, Inc.
Study Director: Puma Biotechnology
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00397046     History of Changes
Other Study ID Numbers: 3144A1-104
First Posted: November 8, 2006    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by Puma Biotechnology, Inc.:
Advanced Malignant Solid Tumors