Lead Sponsor

Genta Incorporated

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•At least 18 years of age
•Histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis
•Measurable disease (revised RECIST; Version 1.1)
•Karnofsky performance status ≥ 60%
•Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent
•Adequate bone marrow, hepatic, and renal function, as specified in the protocol
•At least 4 weeks and recovery from effects of prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent
•Ability to swallow an oral solid-dosage form of medication

•Known metastasis or symptoms of metastasis to the central nervous system
•Significant medical disease other than cancer
•Presence of neuropathy \> Grade 1 (NCI CTC, Version 4.0)
•Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
•Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity

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