| | Requirement |
| 1 | Must have histologically or cytologically confirmed locally advanced or unresectable metastatic urothelial cancer |
| 2 | 18 y/o and above |
| 3 | Life expectancy at least 6 mos |
| 4 | ECOG Performance Status 0-2 |
| 5 | Absolute Neutrophil must be more than 1000;
Platelets must be more than 100,000;
Hemoglobin must be more than or equal to 9.0 |
| 6 | Total bilirubin must be less than or equal to 1.5 ULN;
AST/ALT must be less than or equal to 2.5 x ULN |
| 7 | Men & women of child-bearing potential must use adequate contraception (hormonal, barrier method or abstinence) |
| 8 | For Ph I of the study (Dose Levels 1 or 2): may have 2 or less prior treatments
|
| 9 | For Ph II of the study and Dose Level 3 of Ph I:
Must have measurable disease.
Must not have any prior therapy for advanced disease, except chemotherapy in the adjuvant setting & last dose must have been more than 6 mos
|
| 10 | Patients who are taking drugs that may affect the activity or PK of E7389 Halichondrin analog may be eligible after review |
| 11 | Must sign Informed Consent (including HIPAA authorization) |
| 1 | On dialysis |
| 2 | Taking other investigational agents |
| 3 | Has untreated or unstable brain metastases |
| 4 | Has uncontrolled intercurrent illness including: ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia or psychiatric illness or social situations that would limit protocol compliance
|
| 5 | Pregnant or breastfeeding |
| 6 | HIV positive and is on combination antiretroviral therapy or with CD4+ of less than or equal to 500/mm3 |
