NCT01233947

Study of AFP464 +/- Faslodex in ER + Breast Cancer

A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Tigris Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.

Detailed description

This is a randomized, open-label study. Patients will be randomized in a 1:1 ratio to single arm AFP464, or AFP464+Faslodex. Patients will be treated until disease progression is noted.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
DRUG	AFP464	AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle
DRUG	AFP464 + Faslodex	AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-11-03
• Last updated: 2012-01-09

Locations

1 site across 1 country: United States