Inclusion Criteria:

- Provision of written informed consent

- Male or female aged more than 18 years

- Histologically proven transitional cell carcinoma of the urothelium

- Metastatic or locally advanced disease not amenable to curative surgery and/or
radiotherapy

- Recurrence or progression after at least one chemotherapy regimen and for
unresectable/advanced disease

- No more than 2 lines of previous chemotherapy..

- Measurable disease (RECIST criteria)

- Previously irradiated lesions are not considered measurable- ECOG performance status
of 0, 1 or 2

Exclusion Criteria:

- No prior treatment with anti cancer agents, including radiotherapy, in the last 4
weeks.

- No currently active CNS involvement

- No pregnancy. Women of child bearing potential must have a negative pregnancy test.

- No uncontrolled diabetes

- No symptomatic coronary artery disease, myocardial infarction within the last six
months, congestive cardiac failure greater than New York Heart Association (NYHA)
class II, uncontrolled or symptomatic cardiac arrhythmia