- Must have had prior platinum salt-based chemotherapy for TCC; other prior systemic chemotherapeutic or investigational treatment regimens for TCC are allowed; patient may have had up to three lines of chemotherapy for advanced disease; may have had paclitaxel provided their cancer did not progress while on it, and it was part of an adjuvant or neoadjuvant regimen; prior targeted or biological therapy is permitted except for drugs targeting EGFR and/or HER2; specifically, subjects must meet one or more of the following criteria: (a). Progression after treatment with a regimen that includes a platinum salt (e.g. carboplatin or cisplatin) for Stage IV or recurrent disease OR (b). Disease recurrence within two years (from the date of last dose of chemotherapy or surgery until day the informed consent is signed) of neoadjuvant or adjuvant treatment with a regimen that includes a platinum salt