NCT00538343

RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases

A Phase II Efficacy and Tolerability Study of RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Biogen · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether RTA 744 is effective in the treatment of breast cancer that has metastasized to the brain.

Detailed description

RTA 744 is a novel, anthracycline that has shown the ability to circumvent ATP-binding cassette transporters (Multidrug Resistance Protein 1, Breast Cancer Resistance Protein, P-glycoprotein) in vitro. This action enables RTA 744 to penetrate across the blood brain barrier. In a Phase I safety study, RTA 744 was shown to be generally well tolerated in patients with recurrent glioblastoma multiforme (GBM). Additionally, anti-tumor activity was observed. Breast cancer is known to be sensitive to anthracycline therapy. Based on the preliminary Phase I clinical results and the sensitivity of breast cancer to anthracycline therapy, this Phase II study will investigate the safety and efficacy of RTA 744 in patients with breast cancer and metastatic disease to the brain which has progressed following whole brain irradiation.

Conditions

• Brain Metastases

Interventions

Type	Name	Description
DRUG	berubicin hydrochloride (RTA 744)

Timeline

• Start date: 2007-10-31
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2007-10-02
• Last updated: 2025-05-29

Locations

7 sites across 1 country: United States