Phase 1
Completed N=21
A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors
Source: ClinicalTrials.gov NCT00397046 ↗Enrolled (actual)
21
Serious AEs
28.6%
Results posted
Feb 2018
Primary outcomePrimary: Dose Limiting Toxicity (DLT) — 0; 0; 0; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity (DLT) |
0; 0; 0; 2 | — |
| PRIMARY Maximum Tolerated Dose (MTD) |
240 | — |
| SECONDARY Objective Response Rate (ORR) |
0; 0; 10.0; 20.0 | — |
| SECONDARY Clinical Benefit Rate |
0; 0; 30.0; 40.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00397046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.