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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704158
• Other study ID #: CR011-CLN-20
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 23, 2008
• Last updated: February 2, 2015
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: February 2015
• Source: Celldex Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• CR011-vcMMAE
administered as an intravenous infusion on Day 1 of a 21 day cycle.

Locations

Country	Name	City	State
United States	Georgia Cancer Specialists	Atlanta	Georgia
United States	Florida Cancer Specialists	Ft. Myers	Florida
United States	Hematology Oncology Associates	Lake Worth	Florida
United States	Tennessee Oncology	Nashville	Tennessee
United States	Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
CuraGen Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 can — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients		throughout the study	No
Primary	To determine the MTD of CR011-vcMMAE in breast cancer patients		throughout the study	No
Secondary	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	No

External Links

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