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

Sponsor

CuraGen Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00704158

Collaborator

(none)

Enrollment

Locations

Duration (Months)

8.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: CR011-vcMMAE	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients [throughout the study]
To determine the MTD of CR011-vcMMAE in breast cancer patients [throughout the study]

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) [throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Florida Cancer Specialists	Ft. 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
5	Tennessee Oncology	Nashville	Tennessee	United States	37203