ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES

Zetagen Therapeutics, Inc10 enrolled

Overview

ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine, and a Spinal Instability Neoplastic Score (SINS) ≥3 and ≤9. ZetaMet™ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ is only for implantation into the vertebral body.

This is an open-label single-arm study. Subjects (N=10) will be recruited from up to 4 Investigational Sites in Canada. Key inclusion criteria are metastatic breast cancer to bone with at least one lytic metastatic lesion located in a vertebral body of the spine and a SINS ≥3 and ≤9. ZetaMet™ will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor. Post-operative care will be per standard of care (SOC) at the Investigational Site. Subjects will be followed for 180 days post-treatment. If post-surgical radiation treatment is planned, it should not occur for at least 84 days post-surgery to allow for bone formation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer in the Spine

Interventions

ZetaMet™ (ZetaFuse™ Bone Graft)COMBINATION_PRODUCT

ZetaMet™ (ZetaFuse™ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.

Eligibility

Sex: FEMALEMin age: 22 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 22 (inclusive) and 75 years (inclusive) at the time of enrollment. * Life expectancy of 12 months or more. * Female patient with histologically confirmed diagnosis of primary breast cancer. * Metastatic breast cancer to bone, with or without involvement of other sites (patients with single metastasis qualify) * At least one lytic metastatic lesion located in the vertebral body of the spine. * Normal spinal alignment. * SINS ≥3 and ≤9. * Signed and dated Informed Consent Form (ICF). * Patient is willing and able to participate in required follow-up visits at the Investigational Site and to complete study procedures and questionnaires. Exclusion Criteria: * Vertebral body collapse. * Spinal cord compression. * Known allergy to Investigational Device materials. * Using medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., chronic systemic steroids). * Current tobacco smoker or stopped smoking in past 6 months. * Uncontrolled diabetes mellitus, HbAIC cutoff. * An active systemic infection (e.g., hepatitis, acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC). * Currently participating in any investigational trial not related to this trial. * Any other severe acute or chronic medical condition that may interfere with the interpretation of the trial results, in the judgment of the PI, which would make the patient inappropriate for entry into this trial. * Pregnant or planning to become pregnant during the trial.

Locations (2)

Vancouver Coastal Health Research Institute

Vancouver, British Columbia, Canada

McGill University Health Center

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Number of Skeletal Related Events (SREs)

SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention.

Time frame: Day 0 up to Day 180

Number of subjects with at least one adverse event (AE)

An AE is any unfavorable sign, symptom, or disease temporally associated with study participation, including the use of the Investigational Device and all study procedures. An AE may or may not be related to the use of the Investigational Device or a study procedure. AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition.

Time frame: Day 0 up to Day 180

Number of subjects with at least one procedure-related AE

A procedure-related AE is any unfavorable sign, symptom, or disease temporally associated with any study procedure. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to any study procedure.

Time frame: Day 0 up to Day 180

Number of subjects with at least one device-related AE

A device-related AE is any unfavorable sign, symptom, or disease temporally associated with the Investigational Device. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to the Investigational Device.

Time frame: Day 0 up to Day 180

Change in SINS assessment at 21 days compared to baseline

The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.

Time frame: Day 0 to Day 21 postoperatively

Data from ClinicalTrials.gov

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Change in SINS assessment at 42 days compared to baseline

Time frame: Day 0 to Day 42 postoperatively

Change in SINS assessment at 84 days compared to baseline

Time frame: Day 0 to Day 84 postoperatively

Change in SINS assessment at 180 days compared to baseline

Time frame: Day 0 to Day 180 postoperatively

Change in Short Form 12v2 (SF-12v2) score compared to baseline

The 12-Item Short Form Survey version 2 (SF-12v2) is a shortened version of the SF-36v2 designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. The SF-12v2 is given at baseline and at 180 days postoperatively.

Time frame: Day 0 to Day 180 postoperatively

Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 21 days compared to baseline

The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.

Time frame: Day 0 to Day 21 postoperatively

Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 42 days compared to baseline

Time frame: Day 0 to Day 42 postoperatively

Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 84 days compared to baseline

Time frame: Day 0 to Day 84 postoperatively

Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 180 days compared to baseline

Time frame: Day 0 to Day 180 postoperatively

Change in vertebral body defect size measured by CT at 42 days compared to baseline

Vertebral body defect size measured by CT

Time frame: Day 0 to Day 42 postoperatively

Change in vertebral body defect size measured by planar radiographs at 42 days compared to baseline

Vertebral body defect size and planar radiographs

Time frame: Day 0 to Day 42 postoperatively

Change in vertebral body defect size measured by CT at 180 days compared to baseline

Vertebral body defect size measured by CT

Time frame: Day 0 to Day 180 postoperatively

Change in vertebral body defect size measured by planar radiographs at 180 days compared to baseline

Vertebral body defect size measured by planar radiographs

Time frame: Day 0 to Day 180 postoperatively

Duration of use of postoperative prescription opioid

The average per group duration of intake of opioids in the post-operative setting.

Time frame: Day 180 postoperatively

Daily dose of postoperative prescription opioid use

The average per group dosage of opioids in the post-operative setting.

Time frame: Day 180 postoperatively

Naloxone concentrations in blood collected from patients at 30 minutes following the vertebroplasty procedure

Two blood samples (5 mL each) of whole blood are collected at 30 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia

Time frame: 30 minutes following the placement of the surgical bandage

Naloxone concentrations in blood collected from patients at 60 minutes after the vertebroplasty procedure

Two blood samples (5 mL each) will be collected at 60 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia

Time frame: 60 minutes following the placement of the surgical bandage