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A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer


Main

Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients

Outcome Time Frame:

throughout the study

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CR011-CLN-20

NCT ID:

NCT00704158

Start Date:

June 2008

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • CR011-vcMMAE
  • locally advanced breast cancer
  • metastatic breast cancer
  • breast cancer
  • CuraGen
  • Breast Neoplasms

Name

Location

Hematology Oncology Associates Atlantis, Florida  33462
Georgia Cancer Specialists Decatur, Georgia  30033
Florida Cancer Specialists Fort Myers, Florida  33901
Cornell University New York, New York  10021
Tennessee Oncology Nashville, Tennessee  37203