NCT01221870

Tesetaxel as First-line Therapy for Metastatic Breast Cancer

A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Genta Incorporated · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer. Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
DRUG	Tesetaxel once every 3 weeks	Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months
DRUG	Tesetaxel once weekly	Tesetaxel capsules orally once every 7 days for 3 consecutive weeks in a 28-day cycle; duration of therapy not to exceed 12 months

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2010-10-15
• Last updated: 2012-07-24

Locations

4 sites across 1 country: United States