Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT02464332
Eligibility Criteria:
Inclusion Criteria:
1. Male of female subject aged 18-75 years
2. Diagnosis of soft tissue sarcoma, with scheduled surgical removal for treatment for the disease and completion of chemotherapy or radiation within 4 weeks of BLZ-100 administration
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
5. Available for all study visits and able to comply with all study requirements
Exclusion Criteria:
1. Clinically-suspected and/or pathologically-confirmed sarcoma of the bone (e.g. osteosarcoma, Ewing's sarcoma with bony involvement, chondrosarcoma, Kaposi's sarcoma, extraosseous primitive neuroectodermal tumor \[PNET\])
2. Evidence of metastatic disease
3. Female who is lactating/breastfeeding
4. Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study
5. Karnofsky Performance Status of \<60%
6. Any of the following laboratory abnormalities at Screening:
* Neutrophil count \<1.5 x 10\^9/L
* Platelets \<75 x 10\^9/L
* Hemoglobin \<10 g/dL (may be determined following transfusion)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)
* Total bilirubin \>1.5x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
* Internal Normalized Ratio (INR) \>1.5
* Creatinine \>1.5x ULN
* Calculated estimated glomerular filtration rate (eGFR) ≤60 mL/min
7. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
8. QTc prolongation \>450 msec
9. History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine, and/or hospitalization
10. Uncontrolled asthma or asthma requiring oral corticosteroids
11. Known or suspected sensitivity to imaging agents that may be used in clinical assessment of this study
12. Known or suspected sensitivity to indocyanine green (ICG)
13. Unstable angina, myocardial infarction, known or suspected transient ischemic events, or stroke within 24 weeks of start of Screening
14. Uncontrolled hypertension
15. Initiation of new photosensitizing drugs within 30 days of Screening
16. 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
17. Receipt of an investigational drug or device within 30 days of enrollment
18. Prior administration of BLZ-100
19. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02464332
Study Brief:
Protocol Section:
NCT02464332