NCT02496065

Brief Summary

Surgery is the primary treatment modality for many types of cancer and the extent of surgical resection is directly related to patient survival. However, it is often difficult for surgeons to distinguish normal from neoplastic tissue or to detect metastatic disease or tumor-infiltrated lymph nodes. In some sites, surgical precision is also required to avoid damage to critical normal tissues. The purpose of this exploratory study is to evaluate the intra-operative and ex vivo fluorescence of BLZ-100 in tumor samples from subjects with breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.4 years

First QC Date

July 8, 2015

Last Update Submit

July 11, 2017

Conditions

Tumors, Breast

Keywords

breast cancerBLZ-100Tumor Paintbreast tumors

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters. These assessments will be used to determine whether a subject experienced an AE.

    Seven days after study drug administration

Secondary Outcomes (2)

  • Fluorescent signal from excised tumor surgical specimens

    Post-tumor excision (approximately 2 hours post BLZ-100 dosing)

  • Change of concentration of BLZ-100 in the blood

    5, 15, and 30 minutes post BLZ-100 administration

Study Arms (1)

BLZ-100

EXPERIMENTAL
Drug: BLZ-100

Interventions

BLZ-100DRUG
Also known as: Tumor Paint
BLZ-100

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subject aged 18 years or older.
  • Diagnosed solid tumor scheduled for surgical excision. Subjects with recurrent disease will be eligible only if the duration between last tumor surgery and scheduled new surgery is ≥3 months.
  • Able to provide written informed consent.
  • If of child-bearing potential, agree to continued use of two reliable methods of contraceptive from study entry (time of informed consent) through 30 days after BLZ-100 administration. Male subjects with vasectomy do not need to use a second form of contraceptive.
  • Available for all study visits and able to comply with all study requirements.

You may not qualify if:

  • Suspected central nervous system (CNS) tumor(s) or sarcoma.
  • Female who is lactating/breastfeeding.
  • Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study.
  • Karnofsky Performance Status of \<60%.
  • Any of the following laboratory abnormalities at Screening:
  • Neutrophil count \<1.5 x 109/L
  • Platelets \<75 x 109/L
  • Hemoglobin \<10 g/dL (may be determined following transfusion)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN)
  • Total bilirubin \>1.5 x ULN (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
  • International Normalized Ratio (INR) \>1.5 x ULN
  • Creatinine \>1.5 x ULN
  • QTc prolongation \>480 msec.
  • History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine, and/or hospitalization.
  • Uncontrolled asthma or asthma requiring oral corticosteroids.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Overlake Medical Center

Bellevue, Washington, 98004, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tozuleristide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kristi M Harrington, MD

    Overlake Medical Center, Overlake Medical Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 14, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(2)