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Phase 1/Phase 2
18 Years
Not Enrolling
Advanced Cancer, Pancreatic Cancer

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Trial Information

Inclusion Criteria

Key Inclusion Criteria (Part 1):

- Histologically or cytologically confirmed diagnosis of a solid tumor suitable for
treatment with gemcitabine.

- No more than 3 prior anticancer regimens for advanced disease.

- Measurable or evaluable, nonmeasurable disease.

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

- Able to take and retain oral medications.

- Additional criteria exist.

Key Exclusion Criteria (Part 1):

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

- Treatment with prior chemotherapy within 21 days of first dose of study drug.

- Requiring IV alimentation.

- Pregnancy or lactation.

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

- History of being unable to tolerate gemcitabine or any of its components.

- Additional criteria exist.

Type of Study:


Study Design:

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

Outcome Measure:

Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine.

Outcome Time Frame:

Part 1

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

February 2011

Related Keywords:

  • Advanced Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Neoplasms



University of Colorado Health Sciences Center Denver, Colorado  80262
Premiere Oncology Santa Monica, California  90404
Sarah Cannon Research Center Nashville, Tennessee  37203
Pinnacle Oncology/Hematology Phoenix, Arizona  85258
Partners, Massachusetts General Hospital Boston, Massachusetts  02114
Partners, Dana Farber Boston, Massachusetts  02115