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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE February 20, 2015
First Posted Date  ICMJE March 18, 2015
Last Update Posted Date March 22, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
Official Title  ICMJE A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: AVB-620
Study Arms  ICMJE Experimental: AVB-620
Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.
Intervention: Drug: AVB-620
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2017)
27
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2015)
39
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02391194
Other Study ID Numbers  ICMJE AVB620-C-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avelas Biosciences, Inc.
Study Sponsor  ICMJE Avelas Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avelas Biosciences, Inc.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP