NCT00951054

A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer

A Phase II Study of NK012 in Locally Advanced Non-Resectable and Metastatic Breast Cancer Patients With Triple Negative Phenotype

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Nippon Kayaku Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether NK012 is safe and effective in the treatment of advanced and metastatic triple negative breast cancer.

Detailed description

This is a Phase II, open label, single arm, multicenter study of NK012 in patients with locally advanced non-resectable and metastatic breast cancer with ER-negative, PR negative and HER2-negative phenotype. NK012 will be administered by infusion over 30 minutes once every 28 days (on Day 1 of each cycle). Patients will be screened for UGT1A1 polymorphism prior to enrollment in order to determine their starting dose.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	NK012	30 minute IV infusion once every 28 days. NK012 dose is 28 mg/m\^2 (or 18 mg/m\^2 depending on UGT1A1 polymorphism, with potential to dose escalate). Dose escalation cannot exceed 28 mg/m\^2. Dosing will proceed until progression or unacceptable toxicity develops, or decision by patient or investigator to stop.

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-12-01
• Completion: 2015-02-01
• First posted: 2009-08-04
• Last updated: 2015-02-16

Locations

1 site across 1 country: United States