NCT01113970

Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer

Phase I/II Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase I/II trial of a novel Indibulin dosing schedule for the treatment of metastatic breast cancer. Eligible patients will have measurable or non-measurable, metastatic or unresectable, locally advanced breast cancer and may have received any number of prior therapies for their disease. It is expected that the Phase I portion will enroll up to 20 patients and the Phase II portion will enroll up to 45 patients.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Indibulin	Indibulin given orally once a day for 5 days followed by a 9 day rest

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-04-30
• Last updated: 2013-01-30

Locations

4 sites across 1 country: United States