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Phase 1
18 Years
Not Enrolling
Advanced Cancer

Thank you

Trial Information


Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer
suitable for treatment with capecitabine. Pancreatic cancer is not allowed and
patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if
prior treatment did not include a total gastrectomy.

- Target lesions may be in a previously irradiated field only if progression of the
lesion has been clearly documented.

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

- Must be able to take and retain oral medications.

- Additional criteria exist.

Key Exclusion Criteria:

- Active concomitant malignancies.

- 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).

- Known dihydropyrimidine dehydrogenase (DPD) deficiency.

- Requiring intravenous (IV) alimentation.

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

- Pregnancy or lactation.

- Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21
days prior to first dose of study drug.

- Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy
within 14 days prior to first dose of study drug.

- History of any hypersensitivity to or intolerance of capecitabine or any of its
components, or to fluorouracil or any fluoropyrimidine therapy.

- 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 in combination with capecitabine.

Outcome Time Frame:

Duration of study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

April 2011

Related Keywords:

  • Advanced Cancer
  • Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
University of Colorado Cancer Center Denver, Colorado  80262