NCT00412412

CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study

A Ph1 Open-Label,Dose-Escalation,Safety,PK & PD Study of CNF2024 as a Single-Agent Treatment in Subjects w/HER2- Adv Breast Cancer or in Combo w/Trastuzumab in Subjects w/HER2+ Advanced Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to: * find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely * measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood * determine if CNF2024 as a single agent or in combination with trastuzumab can stop breast cancer cells from growing

Detailed description

A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 as a Single-Agent Treatment in Subjects with HER2- Advanced Breast Cancer or in Combination with Trastuzumab in Subjects with HER2+ Advanced Breast Cancer

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	CNF2024	Oral doses of CNF2024 as specified in the protocol.
DRUG	CNF2024 + trastuzumab	Oral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert.

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2006-12-18
• Last updated: 2012-06-08

Locations

3 sites across 1 country: United States