Trial | NCT02391194  Report issue

Title

Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    avb-620 ...

  • Study Participants

    27
This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.
This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.
Study Started
Apr 30
2015
Primary Completion
Jan 31
2017
Study Completion
Jan 31
2017
Last Update
Mar 22
2017

Drug AVB-620

AVB-620 Experimental

Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.

Criteria 

Inclusion Criteria:

Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast
Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate renal function
Lab values (hematology and chemistry) within institution's normal laboratory limits
Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure
If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)
If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits
Subject has the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Recurrent ipsilateral breast cancer
Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.
Open surgery in the ipsilateral breast within 1 year of AVB-620 administration
History of radiation therapy to ipsilateral breast
Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration
Diagnosis of autoimmune disorders
History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded
History of renal disease or current evidence of renal disease
Current diagnosis of any other active or clinically significant non-breast cancer
Systemic investigational drug of any kind within 6 weeks of AVB-620 administration
Pregnant or breast feeding
No Results Posted