A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors
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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
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.
Safety and Tolerability of Neratinib of MTD [ Time Frame: First dose date through 21 days ]
Number of subjects with dose-limiting toxicity (DLT). DLT was assessed from the time of administration of the first single dose to the end of 14 days of continual treatment (i.e., during 21 days from the first dose in the single dose period).
Secondary Outcome Measures
Objective Response Rate [ Time Frame: From first dose date to progression/PD or last tumor assessment ]
Subjects with CR or PR. Objective response rate according to recist criteria.
Clinical Benefit Rate [ Time Frame: From first dose date to progression/death or last assessment ]
Subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), or Stable Disease (SD) >= 24 weeks.
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Ages Eligible for Study:
20 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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