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Phase 1
18 Years
Not Enrolling
Advanced Cancer

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Trial Information

Inclusion Criteria

Key Inclusion Criteria (Part 2):

- Histopathologically or cytologically confirmed solid tumor that is refractory to
standard therapies, or for which no standard therapies exist, or for which the
Investigator feels no other active therapy is required for the duration of the study.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.

- Estimated life expectancy of greater than or equal to 3 months.

- Patient must have a tumor that is accessible for biopsy and must consent to paired
tumor biopsies and normal skin biopsies being taken pre- and post-dose of study drug.

- Additional criteria exist.

Key Exclusion Criteria (Part 2):

- Uncontrolled or symptomatic brain metastases.

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

- Major surgery within 30 days prior to study start.

- Radiotherapy or chemotherapy within 21 days prior to study start (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.

- 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:

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

Outcome Time Frame:

Part 1

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

February 2007

Related Keywords:

  • Advanced Cancer
  • Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Mayo Clinic Rochester Rochester, Minnesota  55905
University of Colorado Cancer Center, Anschutz Cancer Center Aurora, Colorado  80010