Any ongoing toxicity from prior anti-cancer treatment that, in the judgment of the investigator, may interfere with study treatment; all toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version ) or baseline prior to registration Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational therapy in the days before the first dose of study treatment (subjects with prior cytotoxic or investigational products < weeks prior to study treatment might be eligible after discussion between the Investigator and Medical Monitor, if toxicities from the prior treatment have been resolved to NCI CTCAE Grade ). All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade or baseline before the first dose of study treatment. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enrol All toxicities attributed to prior anti-cancer therapy other than alopecia, fatigue, or peripheral neuropathy must have resolved to grade (National Cancer Institute [NCI] CTCAE version ) or baseline before administration of study drug All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version .) or baseline prior to administration of first dose of study drug; subjects with toxicities attributed to prior anti-cancer therapy that are not expected to resolve and result in long-lasting sequelae, such as chronic neuropathy after platinum based therapy, are permitted to enroll Subjects with toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue that have not resolved to grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events\r\n[CTCAE] version .) or baseline before administration of study drug. STUDY TREATMENT: All toxicities attributed to prior anti-cancer therapy other than nephropathy, neuropathy, hearing loss, alopecia and fatigue must have resolved to grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version ) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll All toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia and fatigue must have resolved to grade (National Cancer institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version ) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll; neuropathy must have resolved to grade (NCI CTCAE version ) Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to grade (National Cancer Institute Common Terminology Criteria for Adverse Events version .) or baseline before administration of study drug Any ongoing toxicity from prior anti-cancer treatment that, in the judgement of the investigator, may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade (NCI CTCAE version ) or baseline prior to enrollment. Eligible patients must not require more than mg/day prednisone (or equivalent dose). Prior systemic chemotherapy for indications other than urothelial cell carcinoma of the bladder is permitted. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade (National Cancer Institute CTCAE version .) or baseline before administration of study drug. Participants with toxicities attributed to prior anti cancer therapy which are not expected to resolve and result in long lasting sequelae, such as peripheral neuropathy after platinum-based therapy or audiometric hearing loss, are permitted to enroll. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v] .) or baseline before administration of study treatment. Participants with toxicities attributed to prior anti-cancer therapy that are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum-based therapy, are permitted to enroll All toxicities attributed to prior anti-cancer therapy must have been resolved to grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version ) or baseline before administration of study drug(s) other than:\r\n* Patients with toxicities attributed to prior anti-cancer therapy that either are not expected to resolve and/or result in long-lasting sequelae, such as neuropathy after platinum-based therapy, or are not expected to interfere with treatment on study, such as fatigue, alopecia, or grade hematologic toxicity are eligible All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version (v) grade =< (except alopecia) at the time of registration; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae are permitted to enroll No ongoing toxicity from prior anti-cancer treatment that may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade or baseline before administration of the study treatment. Subjects with toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue that have not resolved to grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version ) or baseline before administration of study drug All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade (National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version .) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long-lasting sequelae, such as neuropathy after chemotherapy, are permitted to enroll All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade (Common Terminology Criteria for Adverse Events [CTCAE] version ) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy and which are not expected to resolve and result in long lasting sequelae such as neuropathy after platinum-based therapy, are permitted to enroll Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to grade (Common Terminology Criteria for Adverse Events [CTCAE] version .) or baseline before administration of study drug