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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391194
• Other study ID #: AVB620-C-001
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2015
• Last updated: March 21, 2017
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Avelas Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• AVB-620

Locations

Country	Name	City	State
United States	Moores UC San Diego Cancer Center	La Jolla	California
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Stanford Hospitals and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Avelas Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values	The incidence, nature and severity of adverse events and abnormal laboratory values will be collected and analyzed in the evaluation of the safety of AVB-620.	30 days
Secondary	Characterize the pharmacokinetic profile of AVB-620	The pharmacokinetics (PK) of AVB-620 will be characterized by collecting and reviewing individual subject plasma concentrations and primary parameters, including clearance, Cmax, Cmin, and distribution.	8 days