Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
CuraGen Corporation
ClinicalTrials.gov Identifier:
NCT00704158
First received: June 23, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: CR011-vcMMAE
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by CuraGen Corporation:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To determine the MTD of CR011-vcMMAE in breast cancer patients [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of efficacy (progression-free survival rate at 12 weeks, objective response rate, time to response, duration of response and time to progression) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CR011-vcMMAE
    administered as an intravenous infusion on Day 1 of a 21 day cycle.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704158

Locations
United States, Florida
Florida Cancer Specialists
Ft. Myers, Florida, United States, 33916
Hematology Oncology Associates
Lake Worth, Florida, United States, 33461
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
United States, New York
Cornell University
New York, New York, United States, 10065
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
CuraGen Corporation
  More Information

No publications provided

Responsible Party: Vice President, Clinical Development, Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT00704158     History of Changes
Other Study ID Numbers: CR011-CLN-20
Study First Received: June 23, 2008
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by CuraGen Corporation:
CR011-vcMMAE
locally advanced breast cancer
metastatic breast cancer
breast cancer
CuraGen

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014