Tesetaxel for Previously Treated Patients With Bladder Cancer

PHASE2UnknownINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

September 30, 2012

Study Completion Date

December 31, 2012

Conditions
Carcinoma, Transitional Cell
Interventions
DRUG

Tesetaxel

"Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months~In Cycle 1, a dose of 27 mg/m2 will be administered. In subsequent cycles,~* the dose will be increased to 35 mg/m2 in Cycle 2 for subjects who did not have an ANC \< 1,500/mm3, a platelet count \< 100,000/mm3, or a Grade 3 (or higher grade) nonhematologic adverse event considered by the Investigator to be related to protocol therapy (excluding alopecia, nausea, and vomiting) in Cycle 1. The dose is not to exceed the dose of 35 mg/m2 in any cycle subsequent to Cycle 2.~* for all other subjects, the dose administered in Cycle 1 (27 mg/m2) will be administered in all subsequent cycles."

Trial Locations (3)

10065

RECRUITING

Memorial Sloan-Kettering Cancer Center, New York

19107

RECRUITING

Thomas Jefferson University Hospital, Philadelphia

00152

RECRUITING

San Camillo Forlanini Hospital, Rome

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genta Incorporated

INDUSTRY