Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer
NCT00704158 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2015-02-19
Summary
This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.
Conditions
Interventions
- DRUG
-
CR011-vcMMAE
administered as an intravenous infusion on Day 1 of a 21 day cycle.
Sponsors & Collaborators
-
CuraGen Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2010-11-30
- Completion
- 2011-06-30
Countries
- United States
Study Locations
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