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
- 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 firstname.lastname@example.org and include "Expanded Access Request" in the subject.
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:
- Adequate supply of the investigational drug tozuleristide must be available above and beyond the supply needed for Blaze Bioscience clinical trials;
- There is sufficient clinical data to identify an appropriate dose of the investigational drug;
- There is a good understanding of the patient's clinical situation and investigational drug proposed use for surgery including the proposed fluorescence detection device;
- All available therapeutic approaches for the patient's disease have been exhausted by the patient and their physicians;
- 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;
- Providing the investigational drug is compliant with all applicable rules and laws;
- Appropriate Institutional Review Board/Ethics Committee and FDA authorization requested expanded access has been obtained;
- Treating physician understands and is willing to be responsible for ensuring that the patient informed consent requirements are met; and
- Treating physician understands and is willing to be the holder of a treatment IND with FDA.
- Timing of acknowledgement: Blaze Bioscience endeavors to acknowledge requests within ten (10) business days of receipt of an Expanded Access Request.
- 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|
|See clinical trials of the intervention/treatment in this expanded access record.|
- Drug: Tozuleristide
- Tumor Paint
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343274
|Contact: Blaze Bioscience Expanded Accessemail@example.com|
|Contact: Blaze Bioscience Infofirstname.lastname@example.org|