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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02234297




Registration number
NCT02234297
Ethics application status
Date submitted
4/08/2014
Date registered
9/09/2014
Date last updated
6/04/2016

Titles & IDs
Public title
Safety Study of BLZ-100 in Adult Subjects With Glioma Undergoing Surgery
Scientific title
A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Glioma Undergoing Surgery
Secondary ID [1] 0 0
BB-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BLZ-100

Experimental: BLZ-100 -


Treatment: Drugs: BLZ-100
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events
Timepoint [1] 0 0
Seven days after study drug administration
Secondary outcome [1] 0 0
Change in concentration of BLZ-100 in the blood
Timepoint [1] 0 0
Prior to dosing and at 1 minute, 5 minutes, 15 mins, 30 mins, 60 mins and 120 mins after end of injection

Eligibility
Key inclusion criteria
1. Male or female subjects aged 18- 75 years.

2. Subjects must have glioma for which surgical resection is clinically indicated. Grade
I, II, III and IV glioma patients will be included (for example glioblastoma,
astrocytoma, and oligodendroglioma). Histological confirmation not required prior to
surgery. Subjects with recurrent disease will be eligible only if the duration between
last brain surgery and scheduled new surgery is =3 months. The grade of a recurrent
tumor will be presumed that of the primary tumor for purposes of group allocation.

3. Able to provide written informed consent.

4. If of child-bearing potential, agree to the continued use of effective contraceptive
from study entry (Informed consent) through 30 days after BLZ-100 administration.

5. Available for all study visits and able to comply with all study requirements
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence of metastatic disease.

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 10^9/L

2. Platelets <75 x 10^9/L

3. Hemoglobin <10 g/dL (may be determined following transfusion)

4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x upper
limit of normal (ULN)

5. Total bilirubin >1.5x upper limit of reference range (unless Gilbert's syndrome
or extrahepatic source as denoted by increased indirect bilirubin fraction)

6. International Normalized Ratio (INR) >1.5

7. Creatinine >1.5x ULN

6. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or
hepatitis B virus (HBV).

7. QTc prolongation >450 msec

8. History of hypersensitivity or allergic reactions requiring corticosteroids,
epinephrine and/or hospitalization.

9. Uncontrolled asthma or asthma requiring oral corticosteroids.

10. Known or suspected sensitivity to MRI contrast agents or excipients in the study drug
product.

11. Known or suspected sensitivity to Indocyanine green (ICG).

12. Unstable angina, myocardial infarction, known or suspected transient ischemic events
or stroke within 24 weeks of start of Screening.

13. Uncontrolled hypertension.

14. Receipt of photosensitizing drugs within 30 days of Screening.

15. Any ongoing medications which might generate fluorescence or according to 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.

16. Received an investigational drug or device within 30 days of enrollment.

17. Prior treatment with BLZ-100.

18. 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.

-

Study design
Purpose of the study
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
NEWRO Foundation - Brisbane
Recruitment postcode(s) [1] 0 0
Auchenflower - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Blaze Bioscience Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 incomplete removal of the tumor and reduced
patient survival. 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
operate. This is a safety study to assess the safety of BLZ-100 in patients with gliomas
undergoing surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02234297
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chirag Patil
Address 0 0
Cedars-Sinai Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02234297