The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium

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