NCT01215877

Tesetaxel for Previously Treated Patients With Bladder Cancer

A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Genta Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients. Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.

Conditions

• Carcinoma, Transitional Cell

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2010-10-07
• Last updated: 2012-07-11

Locations

3 sites across 2 countries: United States, Italy