Status:
COMPLETED
A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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 b...
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Diagnosis of metastatic or advanced cancer that has failed standard effective therapy
- Life expectancy of at least 12 weeks and adequate performance status
- Adequate bone marrow, kidney and liver function
- Willingness of male and female subjects who are not surgically sterile or post-menopausal to use adequate methods of birth control
- Exclusion Criteria
- Any anticancer chemotherapy, radiotherapy immunotherapy or investigational agents within 4 weeks of first dose of HKI-272
- Inadequate cardiac function
- Surgery within 2 weeks of first dose of HKI-272
- Active central nervous system metastases (i.e., symptomatic, required use of corticosteroids and/or progressive growth)
- Significant gastrointestinal disorder with diarrhea as a major symptom
- Pregnant or breast feeding women
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00397046
Start Date
November 1 2006
End Date
March 1 2009
Last Update
September 14 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto, Tokyo, Japan, 135-8550
2
Shizuoka Cancer Center
Shizuoka, Japan, 1411-8777