Clinical trial NCT00704158: Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer
Official title: A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: CR011-vcMMAE
locally advanced breast cancer
metastatic breast cancer
breast cancer
CuraGen
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients
timeFrame: throughout the study
measure: To determine the MTD of CR011-vcMMAE in breast cancer patients
timeFrame: throughout the study
Secondary outcomes:
measure: Evaluation of efficacy (progression-free survival rate at 12 weeks, objective response rate, time to response, duration of response and time to progression)
timeFrame: throughout the study
Other outcomes:
Locations:
city: Ft. Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Lake Worth
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: New York
country: United States
facility: Cornell University
state: New York
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
References:
citation: 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.