Inclusion Criteria:

1. Signed and dated IRB/IEC-approved Informed Consent.

2. Cytological or histological diagnosis of locally advanced or metastatic
adenocarcinoma of the biliary tract (Ampulla of Vater, gallbladder, intra or
extra-hepatic biliary ducts).

3. Disease progressing after first-line chemotherapy with gemcitabine and platinum
analogs (only one prior systemic therapy allowed).

4. Age 18-75 years

5. Karnofsky Performance Status > 50%

6. Estimated life expectancy of at least 3 months.

7. Negative pregnancy test (if female in reproductive years).

8. Adequate bone marrow, liver and kidney function: leukocyte > 3500/mm3; absolute
neutrophil count (ANC) > 1500/mm3; platelet count > 100000/mm3; hemoglobin > 10 g/dl;
creatinine < 1.5 mg/dL; total bilirubin ≤ 1.5 x upper limit of normal range (ULN);
SGOT e SGPT ≤ 2.5 ULN

9. At the time of start of treatment, at least 2 weeks must have elapsed since
completion of prior chemotherapy, minor surgery and radiotherapy (provided that no
more than 25% of bone marrow reserve has been irradiated).

10. Resolution of all acute toxic effects of any prior chemotherapy, surgery or
radiotherapy to NCI CTC (Version 4.03) grade ≤ 1 for hematologic toxicities and ≤ 2
for non hematologic toxicities, with the exception of alopecia.

11. Able and willing to comply with scheduled visits, therapy plans, and laboratory tests
required in this protocol.

Exclusion Criteria:

1. Previous or concurrent malignancies at other sites with the exception of surgically
cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the
skin and of other neoplasm without evidence of disease at least from 5 years.

2. Known brain metastases.

3. Previous second-line or adjuvant treatment.

4. Concurrent treatment with other experimental drugs.

5. Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, cardiac arrhythmia) ≤1 year
prior to dosing.

6. Clinically significant disease including: Cerebral Vascular Accident; other serious
underlying medical condition(s) which could impair the ability of the patient to
participate in the study.

7. History of interstitial lung disease (eg, pneumonia or pulmonary fibrosis) or
evidence of interstitial lung disease on baseline chest CT scan

8. Known positive tests for human immunodeficiency virus (HIV) infection, active
hepatitis B or hepatitis C

9. Subject who is pregnant or breast feeding

10. Woman or man of child-bearing potential not consenting to use adequate contraceptive
precautions ie. double barrier contraceptive methods (e.g., diaphragm plus condom),
or abstinence during the course of the study and for 6 months after the last study
drug administration for women, and 1 month for men

11. Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule