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Phase 1
18 Years
Not Enrolling
Advanced Cancer

Thank you

Trial Information

Inclusion Criteria

Key Inclusion Criteria (Part 2):

- Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer,
pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma,
ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or
other relevant cancers if approved in advance by the Sponsor.

- Measurable disease (at least 1 target lesion) according to modified RECIST.

- Failed at least one previous therapeutic regimen and either no longer a candidate for
standard therapy, has no standard therapy available, or chooses not to pursue
standard therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

- Must consent to allow the Sponsor access to an archival histological specimen or to
have a pre-dose tumor biopsy.

- Additional criteria exist.

Key Exclusion Criteria (Part 2):

- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and
is on steroids, the steroid dose must be stable for at least 30 days).

- Use of an investigational medication or device within 30 days prior to first dose of
study drug.

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

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

- Pregnancy or lactation.

- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B
and/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they
may be enrolled even if they are positive for hepatitis B and/or hepatitis C.

- Additional criteria exist.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the maximum tolerated dose (MTD) of study drug.

Outcome Time Frame:

Part 1

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

June 2009

Related Keywords:

  • Advanced Cancer
  • ErbB2+ Breast Cancer
  • HER2+ Breast Cancer
  • Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Sarah Cannon Research Center Nashville, Tennessee  37203