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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: CNF2024; Drug: CNF2024 + trastuzumab

• Registration Number: NCT00412412
• Lead Sponsor: Biogen

Brief 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

Study Timeline

• Study First Submitted: 2006-12-15
• Study First Submitted QC: 2006-12-15
• Study First Posted: 2006-12-18
• Study Start: 2007-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-12
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	CNF2024	Patients with HER2- Breast Cancer
B	CNF2024 + trastuzumab	Patients with HER2+ Breast Cancer

Primary Outcome Measures

Name	Time	Method
Clinical and laboratory safety assessments	30 days after discontinuation of CNF2024 or until drug-related toxicites have returned to less than Grade 1

Trial Locations

Locations (2)

Research Site; 🇺🇸 New York, New York, United States

Research site; 🇺🇸 Houston, Texas, United States