Key
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.