NCT00043394

CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.

Conditions

• Carcinoma, Breast

Interventions

Type	Name	Description
DRUG	0.04 mg/kg CpG 7909	0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
DRUG	Herceptin®	Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
DRUG	0.08 mg/kg CpG 7909	0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
DRUG	Herceptin®	Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
DRUG	0.12 mg/kg CpG 7909	0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
DRUG	Herceptin®	Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
DRUG	0.16 mg/kg CpG 7909	0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
DRUG	Herceptin®	Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.

Timeline

• Start date: 2002-09-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2002-08-12
• Last updated: 2009-03-12

Locations

12 sites across 1 country: United States