A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00397046
First received: November 7, 2006
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Tumors
Drug: neratinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • Safety will be assessed through adverse event evaluation, physical exams, and laboratory evaluations. Efficacy will be assessed through radiographic evaluation. [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: November 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: neratinib
    HKI-272
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397046

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

No publications provided by Puma Biotechnology, Inc.

Additional 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
Study First Received: November 7, 2006
Last Updated: May 10, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014