or
forgot password

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
Not Enrolling
Both
Breast Neoplasms

Thank you

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