CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study
NCT00412412 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2012-06-08
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
Conditions
Interventions
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-12-31
- Primary Completion
- 2011-04-30
- Completion
- 2011-04-30
Countries
- United States
Study Locations
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