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Skin NeoplasmsPhase 1NCT02097875

Safety Study of a Fluorescent Marker to Visualize Cancer Cells

A Phase 1 study testing BLZ-100 in people with Skin Neoplasms, run by Blaze Bioscience Australia Pty Ltd at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Neoplasms
What is being tested?
BLZ-100
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteAustralia
Study dates
Dec 2013to Mar 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients age ≥ 18 years.
  • Known or suspected non-metastatic basal cell or squamous cell carcinomas ≥10 mm longest diameter or non-metastatic melanoma ≥6 mm longest diameter scheduled for excision, without advanced disease.
  • Written Informed Consent.
  • Agree to the use of effective contraceptive from Baseline and for 30 days after treatment if either male or female of child bearing potential.
  • Available for and able to comply with study requirements.

Who cannot join

  • Women who are lactating/breastfeeding
  • Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study.
  • Life expectancy <6 months.
  • Karnofsky Performance Status of ≤70%.
  • The following laboratory abnormalities:
  • Neutrophil count <1.5 x 10^9/L
Show all 23Show fewer
  • Platelets <75 x 10^9/L
  • Haemoglobin <10 g/dL (may be determined following transfusion)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN)
  • Total bilirubin >2x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
  • International Normalized Ratio (INR) >1.5
  • Creatinine >1.5x ULN
  • History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization.
  • Uncontrolled asthma or asthma requiring oral corticosteroids.
  • Clinically significant chronic inflammatory skin conditions, including psoriasis, atopic dermatitis and scleroderma, as determined by the investigator.
  • Unstable angina, myocardial infarction, known or suspected transient ischemic events or stroke within 24 weeks of Screening.
  • Uncontrolled hypertension.
  • QTc (corrected QT interval) prolongation >450 msec.
  • Receipt of photosensitising drugs within 30 days of screening.
  • Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
  • Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data.
  • Known or suspected sensitivity to study product or excipients.
  • Prior participation in this clinical trial (has received study product).

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer

Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time, as they operate.

Conditions
Skin Neoplasms
Being tested
BLZ-100
Keywords
Skin cancer, Basal cell carcinoma, Squamous cell carcinoma, Melanoma
Medical subject headings
Skin Neoplasms, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BLZ-100Drug

Study groups in NCT02097875
Study groupRoleWhat they receive
BLZ-100ExperimentalA single dose of BLZ-100 (1, 3, 6, 12 or 18 mg) will be administered by intravenous injection approximately 48 hours prior to planned excision of skin tumor.
Receives: Drug: BLZ-100

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.

    Measured: Within at least 1 week from baseline

Secondary outcomes (2)

  1. Change in concentration of BLZ-100 in the blood

    BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.

    Measured: Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose

  2. Determination of a dose level for Phase 2 studies

    Measured: At end of study - approximately 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02097875
Sponsor's protocol ID
BB-001
Other IDs
ACTRN12614000115639
Status last verified
Apr 2015
First submitted
25 Mar 2014
Last updated
21 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Yamada M, Miller DM, Lowe M, Rowe C, Wood D, Soyer HP, Byrnes-Blake K, Parrish-Novak J, Ishak L, Olson JM, Brandt G, Griffin P, Spelman L, Prow TW. A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients. Contemp Clin Trials Commun. 2021 Aug 4;23:100830. doi: 10.1016/j.conctc.2021.100830. eCollection 2021 Sep.

    PubMed 34401600

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BLZ-100 in people with Skin Neoplasms, run by Blaze Bioscience Australia Pty Ltd at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: Within at least 1 week from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02097875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.

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