An Ascending Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Subjects With HER-2/NEU or HER-1/EGFR-Positive Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Neoplasms
Both
Breast Neoplasms
Trial Information
An Ascending Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Subjects With HER-2/NEU or HER-1/EGFR-Positive Tumors
Inclusion Criteria:
- Her2/neu or Her1/EGFR positive cancer
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
- Measurable disease as defined by RECIST (Response Evaluation Criteria in Solid
Tumors)
Exclusion Criteria:
- Prior treatment with anthracyclines with a cumulative dose of doxorubicin or
equivalent of greater than 300 mg/m2
- Patients with significant cardiac risk factors
- Active central nervous system metastasis
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Adverse events will be assessed on a continuous basis, physical exam, ECG, and ECOG performance status will be done at the beginning of every 1 month cycle. Laboratory evaluations will be performed approximately every 14 days.
Principal Investigator
Puma
Investigator Role:
Study Director
Investigator Affiliation:
Biotechnology
Authority:
United States: Food and Drug Administration
Study ID:
3144A1-102
NCT ID:
NCT00146172
Start Date:
November 2003
Completion Date:
January 2007
Related Keywords:
- Breast Neoplasms
- Tumors
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Cleveland, Ohio 44195 | |
| Nashville, Tennessee 37203-1632 | |
| Boston, Massachusetts |
