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Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery

24 mei 2016 bijgewerkt door: Blaze Bioscience Inc.

A Phase 1 Study of BLZ-100 Administered by Intravenous Injection in Subjects With Soft Tissue Sarcoma Undergoing Surgery

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, and failure to surgically remove a cancer-affected lymph node or residual cancer at the surgical margin reduces a patient's chance of survival. Moreover, damage to adjacent normal tissue during surgery can result in significant morbidity. The investigators 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. This is a safety study to assess the safety of BLZ-100 in patients with soft tissue sarcoma undergoing surgery.

Studie Overzicht

Toestand

Ingetrokken

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Subjects who provide voluntary written informed consent will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.

This is a two part study:

Part 1 - Dose Finding: Subjects will be required to arrive at the phase 1 unit for dosing 2-3 days prior to the planned surgical excision. Two dose levels of BLZ-100 (3 mg and 12 mg) will be evaluated in a total of 6 subjects with a 2-3 day post-dose imaging interval (also defined as the Intermediate Imaging interval).

Part 2 - Imaging Interval Assessment: The BLZ-100 dose to be evaluated in Part 2 will be determined by the Protocol Steering Committee following completion of Part 1. In Part 2, up to 15 additional subjects will be randomized into one of three imaging interval groups (up to 6 subjects per group): Early Imaging (within 1 day post BLZ-100 dose), Intermediate Imaging (2-3 days post BLZ-100 dose), and Late Imaging (4-7 days post BLZ-100 dose). Subjects will be required to arrive at the phase 1 unit for dosing between 1 and 7 days prior to planned surgical excision, depending on which imaging interval they are randomized to.

Following dosing, all subjects will be monitored for safety.

Studietype

Ingrijpend

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90048
        • Cedars-Sinai Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: BLZ-100

All participants in the study will receive the investigational drug product BLZ-100.

In part 1 of the study, two dose levels of BLZ-100 will be evaluated (3 mg and 12 mg) in 6 subjects, with a 2-3 post-dose imaging window.

In part 2 of the study up to 15 additional subjects will be randomized to one of three imaging interval groups (up to 6 subjects/interval): Early Imaging (within 1 day post-BLZ-100 dose), Intermediate Imaging (2 - 3 days post- BLZ-100 dose), and Late Imaging (4 - 7 days post- BLZ-100 dose).
Geneesmiddel: BLZ-100

All subjects enrolled in the study will receive doses of BLZ-100, an investigational drug for imaging tumors.

Three different imaging windows will be investigated during the study:

Early Imaging (imaging occurs within 1 day post-BLZ-100 dose); Intermediate Imaging (imaging occurs within 2-3 days post-BLZ-100 dose); Late Imaging (imaging occurs 4-7 post-BLZ-100 dose)

All subjects in Part 1 of the study will be imaged in the Intermediate Imaging group. Subjects in Part 2 of the study will be randomized into one of the three imaging groups.

Andere namen:
  • Tumor verf

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Aantal deelnemers met bijwerkingen
Tijdsspanne: Zeven dagen na toediening van het onderzoeksgeneesmiddel
De veiligheid wordt beoordeeld door lichamelijk onderzoek en meting van vitale functies en laboratoriumveiligheidsparameters.
Zeven dagen na toediening van het onderzoeksgeneesmiddel

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change of concentration of BLZ-100 in the blood
Tijdsspanne: Prior to dosing and at 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes and 120 minutes after end of injection, and pre-surgery and 24 hours post-surgery
BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
Prior to dosing and at 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes and 120 minutes after end of injection, and pre-surgery and 24 hours post-surgery
Fluorescence signal from areas of tumor and non-tumor
Tijdsspanne: 1 day post-dose, 2-3 days post-dose, or 3-7 days post-dose
Fluorescent signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
1 day post-dose, 2-3 days post-dose, or 3-7 days post-dose
Ideal combination of dose and imaging interval
Tijdsspanne: 1 day post-dose, 2-3 days post-dose, 3-7 days post-dose
Fluorescent signal will be evaluated in sections of excised tumor and adjacent normal tissue to determine which imaging interval provides the optimal images.
1 day post-dose, 2-3 days post-dose, 3-7 days post-dose

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Blaze Bioscience Inc.

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Charles Forscher, MD, Cedars-Sinai Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2015

Primaire voltooiing (Werkelijk)

1 mei 2016

Studie voltooiing (Werkelijk)

1 mei 2016

Studieregistratiedata

Eerst ingediend

2 juni 2015

Eerst ingediend dat voldeed aan de QC-criteria

4 juni 2015

Eerst geplaatst (Schatting)

8 juni 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

26 mei 2016

Laatste update ingediend die voldeed aan QC-criteria

24 mei 2016

Laatst geverifieerd

1 mei 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BB-003
  • 261201400046C-0-0-1 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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