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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puma Biotechnology, Inc.

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