COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanded Access for BLZ-100 (Tozuleristide)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343274
Expanded Access Status : Available
First Posted : April 13, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Blaze Bioscience Inc.

Tracking Information
First Submitted Date April 9, 2020
First Posted Date April 13, 2020
Last Update Posted Date April 24, 2020
 
Descriptive Information
Brief Title Expanded Access for BLZ-100 (Tozuleristide)
Official Title Not Provided
Brief Summary This is the Blaze Bioscience expanded access program for its investigational drug tozuleristide intended for patients with life-threatening diseases or conditions who have exhausted approved treatment options and are unable to participate in a clinical trial involving the investigational drug tozuleristide.
Detailed Description
  1. Contact Information: A licensed treating physician may submit questions or requests on behalf of a patient regarding expanded access to tozuleristide to be evaluated in accordance with Blaze Bioscience company policies. Physician Expanded Access Requests should be submitted in writing to expandedaccess@blazebioscience.com and include "Expanded Access Request" in the subject.
  2. Request Procedures:

    1. General Criteria: Blaze Bioscience will evaluate and respond to each Expanded Access Request individually and on a case-by-case basis. Criteria Blaze Bioscience will use in its evaluation of whether to grant Expanded Access Request include:

      1. Adequate supply of the investigational drug tozuleristide must be available above and beyond the supply needed for Blaze Bioscience clinical trials;
      2. There is sufficient clinical data to identify an appropriate dose of the investigational drug;
      3. There is a good understanding of the patient's clinical situation and investigational drug proposed use for surgery including the proposed fluorescence detection device;
      4. All available therapeutic approaches for the patient's disease have been exhausted by the patient and their physicians;
      5. The investigational drug is considered an "eligible investigational drug" under Section 561(B)(2) of the FDCA at the time of the Expanded Access Request;
      6. Providing the investigational drug is compliant with all applicable rules and laws;
      7. Appropriate Institutional Review Board/Ethics Committee and FDA authorization requested expanded access has been obtained;
      8. Treating physician understands and is willing to be responsible for ensuring that the patient informed consent requirements are met; and
      9. Treating physician understands and is willing to be the holder of a treatment IND with FDA.
    2. Timing of acknowledgement: Blaze Bioscience endeavors to acknowledge requests within ten (10) business days of receipt of an Expanded Access Request.
    3. Clinical trials: Blaze Bioscience lists its active clinical trials on clinicaltrials.gov. Before granting an Expanded Access Request for tozuleristide, written confirmation by the treating physician that the patient is not eligible for an active Company clinical trial is needed prior to consideration of the Expanded Access Request.
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Not Provided
Intervention Drug: Tozuleristide
Other Names:
  • BLZ-100
  • Tumor Paint
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Eligibility Criteria

Inclusion Criteria:

  • Undergoing surgery for suspected or confirmed tumor
  • Not eligible for current clinical trials of tozuleristide
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Contacts
Contact: Blaze Bioscience Expanded Access 206-535-8144 expandedaccess@blazebioscience.com
Contact: Blaze Bioscience Info info@blazebioscience.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04343274
Other Study ID Numbers BLZ-100EA
Responsible Party Blaze Bioscience Inc.
Study Sponsor Blaze Bioscience Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Blaze Bioscience Inc.
Verification Date April 2020