Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder

Inclusion Criteria

• •1. Patient has carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder.
• •2. Patient must have sufficient tumor tissue available for submission.
• •3. For patients who have received prior cryotherapy, radiofrequency ablation, radioembolization, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, at least 28 days must have elapsed since that therapy, and lesions that have not been treated with local therapy must be present and measurable.
• •4. Patients may have received prior adjuvant chemotherapy with gemcitabine with or without cisplatin, as long as 6 months have elapsed since last treatment.
• •5. Patients must have one or more tumors measurable on radiographic imaging as defined by RECIST.
• •6. ECOG PS of 0 or 1. Patients with an ECOG PS of 2 may be entered upon review and approval of the medical monitor.
• •7. Estimated life expectancy of at least 3 months.
• •8. Disease-free of active second/secondary or prior malignancies for ≥ 2 years with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
• •9. Adequate hematological, renal, hepatic and coagulation laboratory test results.
• •10. Women of child bearing potential and men must agree to use adequate contraception during the study and for 6 months after their last dose of study drug.
• •11. Available for the duration of the study and are willing to follow study-specific procedures.
• •12. Provide written informed consent