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

February 2, 2015 updated by: CuraGen Corporation

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

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Drug: CR011-vcMMAE

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Ft. Myers, Florida, United States, 33916
    - Florida Cancer Specialists
  - Lake Worth, Florida, United States, 33461
    - Hematology Oncology Associates
- Georgia
  - Atlanta, Georgia, United States, 30341
    - Georgia Cancer Specialists
- New York
  - New York, New York, United States, 10065
    - Cornell University
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients Time Frame: throughout the study	throughout the study
To determine the MTD of CR011-vcMMAE in breast cancer patients Time Frame: throughout the study	throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
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	throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CuraGen Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Bendell J, Saleh M, Rose AA, Siegel PM, Hart L, Sirpal S, Jones S, Green J, Crowley E, Simantov R, Keler T, Davis T, Vahdat L. Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with locally advanced or metastatic breast cancer. J Clin Oncol. 2014 Nov 10;32(32):3619-25. doi: 10.1200/JCO.2013.52.5683. Epub 2014 Sep 29.

Helpful Links

Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with locally advanced or metastatic breast cancer.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria