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

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ClinicalTrials.gov Identifier: NCT02391194
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Avelas Biosciences, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: AVB-620 Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
Study Start Date : April 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: AVB-620
Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.
Drug: AVB-620



Primary Outcome Measures :
  1. Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Characterize the pharmacokinetic profile of AVB-620 [ Time Frame: 8 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391194


Locations
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United States, California
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Stanford Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Avelas Biosciences, Inc.

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Responsible Party: Avelas Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02391194     History of Changes
Other Study ID Numbers: AVB620-C-001
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Avelas Biosciences, Inc.:
AVB-620
stage I
newly diagnosed
breast cancer
stage II
stage III
ductal carcinoma in situ

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases