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Phase 1
18 Years
Not Enrolling

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Trial Information

Inclusion Criteria

Key Inclusion Criteria (Part 1 and Part 2):

- Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic
breast cancer (Part 2).

- Patients should have received at least one previous therapeutic regimen and either no
longer are candidates for standard therapy, have no standard therapy available, or
choose not to pursue standard therapy (patients with HER2+ breast cancer and with
clinical indication for trastuzumab or lapatinib should have received prior therapy
with trastuzumab and lapatinib, if available).

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.

- Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

- Uncontrolled or symptomatic brain metastases (patients may be considered adequately
controlled if on a stable steroid dose for at least 30 days).

- Treatment with an investigational medicinal product or device within 30 days prior to
first dose of study drug.

- Radiotherapy within 28 days prior to first dose of study drug (not including
palliative radiotherapy at focal sites).

- Chemotherapy within 21 days prior to first dose of study drug.

- Major surgery within 30 days prior to first dose of study drug.

- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B
and/or active hepatitis C.

- Additional criteria exist.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

Outcome Time Frame:

Part 1, one year; Part 2, one year

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

March 2013

Related Keywords:

  • Cancer
  • human epidermal growth factor receptor 2
  • epidermal growth factor receptor
  • EGFR
  • type I receptor tyrosine kinase



The University of Texas, MD Anderson Cancer Center Houston, Texas  77030
The University of Colorado Cancer Center Aurora, Colorado