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Exploratory Study of Safety and ex Vivo Fluorescence of BLZ-100 in Adult Subjects With Solid Tumors Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT02496065
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Blaze Bioscience Inc.

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.

Condition or disease Intervention/treatment Phase
Tumors, Breast Drug: BLZ-100 Phase 1

Detailed Description:

Subjects diagnosed to have breast cancer for which surgical resection is clinically indicated will be enrolled in this study.

Upon obtaining signed informed consent, subjects will enter a Screening Period for up to 14 days to determine eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate in the study.

All subjects entered into the study will be required to arrive at the hospital (or Phase 1 unit if applicable) for BLZ-100 administration at least 2 hours before their scheduled surgical procedure. Following administration of BLZ-100, subjects will be continuously monitored for safety and any allergic reaction occurrence for 30 minutes; thereafter, subjects will be evaluated for 7 days after drug administration. All subjects will be followed for at least 30 days following drug administration to monitor for SAEs.

Tumor samples will be imaged in situ and ex vivo with the SIRIS imaging system or equivalent device, processed, and sent to a central laboratory to be evaluated for ex vivo fluorescence using the Odyssey® CLx imaging system.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1 Exploratory Study of the Safety and ex Vivo Fluorescence of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Solid Tumors Undergoing Surgery
Study Start Date : July 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BLZ-100 Drug: BLZ-100
Other Name: Tumor Paint




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Seven days after study drug administration ]
    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.


Secondary Outcome Measures :
  1. Fluorescent signal from excised tumor surgical specimens [ Time Frame: Post-tumor excision (approximately 2 hours post BLZ-100 dosing) ]
    Ex vivo fluorescence of excised tumor specimens will be evaluated with the SIRIS or equivalent imaging device and Odyssey imaging system.

  2. Change of concentration of BLZ-100 in the blood [ Time Frame: 5, 15, and 30 minutes post BLZ-100 administration ]
    BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Male or female subject aged 18 years or older.
  2. 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.
  3. Able to provide written informed consent.
  4. 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.
  5. Available for all study visits and able to comply with all study requirements.

Exclusion Criteria:

  1. Suspected central nervous system (CNS) tumor(s) or sarcoma.
  2. Female who is lactating/breastfeeding.
  3. Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study.
  4. Karnofsky Performance Status of <60%.
  5. Any of the following laboratory abnormalities at Screening:

    1. Neutrophil count <1.5 x 109/L
    2. Platelets <75 x 109/L
    3. Hemoglobin <10 g/dL (may be determined following transfusion)
    4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)
    5. Total bilirubin >1.5 x ULN (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
    6. International Normalized Ratio (INR) >1.5 x ULN
    7. Creatinine >1.5 x ULN
  6. QTc prolongation >480 msec.
  7. History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine, and/or hospitalization.
  8. Uncontrolled asthma or asthma requiring oral corticosteroids.
  9. Known or suspected sensitivity to diagnostic imaging contrast agents.
  10. Known or suspected sensitivity to indocyanine green (ICG).
  11. Unstable angina, myocardial infarction, known or suspected transient ischemic events, or stroke within 24 weeks of start of Screening.
  12. Uncontrolled hypertension.
  13. Initiation of new photosensitizing drugs within 30 days of Screening.
  14. Use of any ongoing medications which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin®, and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix.
  15. Receipt of an investigational drug or device within 30 days of enrollment.
  16. Prior treatment with BLZ-100.
  17. Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would adversely impact the subject or the interpretation of the study data.

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): NCT02496065


Locations
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United States, Washington
Overlake Medical Center
Bellevue, Washington, United States, 98004
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Blaze Bioscience Inc.
Investigators
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Principal Investigator: Kristi M Harrington, MD Overlake Medical Center, Overlake Medical Clinics

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Responsible Party: Blaze Bioscience Inc.
ClinicalTrials.gov Identifier: NCT02496065     History of Changes
Other Study ID Numbers: BB-005
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Keywords provided by Blaze Bioscience Inc.:
breast cancer
BLZ-100
Tumor Paint
breast tumors
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases