NCT00704158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

June 23, 2008

Last Update Submit

February 2, 2015

Conditions

Breast Cancer

Keywords

CR011-vcMMAElocally advanced breast cancermetastatic breast cancerbreast cancerCuraGen

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Interventions

CR011-vcMMAEDRUG

administered as an intravenous infusion on Day 1 of a 21 day cycle.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Hematology Oncology Associates

Lake Worth, Florida, 33461, United States

Location

Georgia Cancer Specialists

Atlanta, Georgia, 30341, United States

Location

Cornell University

New York, New York, 10065, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Related 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 cancer. J Clin Oncol. 2014 Nov 10;32(32):3619-25. doi: 10.1200/JCO.2013.52.5683. Epub 2014 Sep 29.

    PMID: 25267761RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CR011-vcMMAE

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 24, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2010

Study Completion

June 1, 2011

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations

US(5)