Status:
COMPLETED
Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
CuraGen Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 w...
Eligibility Criteria
Inclusion
- Main
- Females with confirmed breast cancer
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- Locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows:
- At least one regimen must have been for locally advanced or metastatic disease
- Subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents
- Hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens
- Subjects with HER2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab
- Documented progressive disease within 6 months of the last regimen
- Adequate bone marrow, renal and liver function
- Signed informed consent
- Main
Exclusion
- Chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start
- Neuropathy \> NCI-CTCAE Grade 1
- Active brain metastases.
- New York Heart Association class III or IV heart disease
- Unstable angina
- Uncontrolled arrhythmia
- A marked baseline prolongation of QT/QTc interval
- Pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00704158
Start Date
June 1 2008
End Date
June 1 2011
Last Update
February 19 2015
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
2
Hematology Oncology Associates
Lake Worth, Florida, United States, 33461
3
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
4
Cornell University
New York, New York, United States, 10065