A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors
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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 |
- 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) |
-
Drug: neratinib
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 |
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
Contacts and Locations 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 |
ClinicalTrials.gov processed this record on May 19, 2013