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Continued Treatment for Participants Enrolled in Studies of BXQ-350 (ETERNITI)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404569
Recruitment Status : Enrolling by invitation
First Posted : May 27, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Bexion Pharmaceuticals, Inc.

Brief Summary:
This is a study to allow continued treatment for participants enrolled in studies of BXQ-350. This study is intended only for those who have completed the required study observation period or are still on treatment upon the closure of their respective BXQ-350 clinical study. The additional treatment is optional and voluntary.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: BXQ-350 Phase 1

Detailed Description:
This is an open-label, multi-center, rollover study to allow continued treatment access for participants enrolled in studies of BXQ-350. This study is intended for subjects who have completed the required study observation period or are still on treatment upon the closure of their respective BXQ-350 clinical study, and who are judged by the Investigator to benefit from continued treatment with BXQ-350. The additional treatment is optional and voluntary.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center, Rollover Study to Provide Continued Treatment Access for Participants Enrolled in Studies of BXQ-350
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continued Treatment

Subjects who have completed the required study observation period or are still on treatment upon the closure of their respective BXQ-350 clinical study, and who are judged by the Investigator to benefit from continued treatment with BXQ-350. Treatment will begin after completion of the End of Study visit of the prior BXQ-350 clinical study.

The established safe dose of BXQ-350 from previous adult and pediatric phase 1 studies is 2.4 mg/kg and 3.2 mg/kg respectively once every 28 days (± 3 days). BXQ-350 will be administered intravenously at the same dose level and frequency the subject was receiving at the end of the prior BXQ-350 clinical study. Subjects receiving a reduced dose at the end of the prior BXQ-350 clinical study due to toxicity may continue to receive a reduced dose.

Drug: BXQ-350
BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 is administered by intravenous (IV) infusion in 28-day cycles
Other Name: SapC-DOPS




Primary Outcome Measures :
  1. Percentage of subjects with clinical benefit [ Time Frame: Day 1 up to approximately 5 years ]
    Subjects will be assessed at every visit for continued clinical benefit as per Investigator's assessment.


Secondary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: Day 1 up to approximately 5 years ]
    Subjects will be assessed at every visit for adverse events

  2. Time to Disease Progression [ Time Frame: From Day 1 until the date of first documented disease progression or date of death from any cause, whichever occurs first; up to approximately 5 years ]
    Subjects will be assessed for disease progression throughout the study per institutional standard of care.

  3. Overall Survival [ Time Frame: From date of BXQ-350 treatment completion until time of death from any cause; up to approximately 5 years ]
    Subjects will be followed monthly for survival upon completion of BXQ-350 treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Each subject must meet the following criteria:

    1. Has participated in and completed all protocol-specified treatments through the required study observation period or time of closure for a prior Bexion-sponsored BXQ-350 clinical study
    2. Has completed the End of Study visit of the prior Bexion-sponsored BXQ-350 clinical study
    3. Did not meet any treatment discontinuation criteria of the original prior Bexion- sponsored BXQ-350 clinical study
    4. Investigator opinion indicates that continued treatment with BXQ-350 is clinically appropriate for the subject
    5. Provide signed, written informed consent prior to the initiation of any study-specific procedures (Consent from Guardians for minor children and patient assent according to Institution and Institutional Review Board (IRB) standards)
    6. Have a negative serum pregnancy test result within 28 days prior to the first continuing treatment assessment for females of child bearing potential (FCBP); not applicable to subjects who are unable to become pregnant, including those with tubal ligation, bilateral oophorectomy and/or hysterectomy)
    7. FCBP and male subjects whose sexual partner(s) are FCBP must agree to abstain from heterosexual activity or use a double barrier method of contraception (e.g., condom and occlusive cap with spermicide) or highly effective contraception (intrauterine device or system, established hormonal contraceptive methods on a stable dose from the time of the last menstrual cycle, or vasectomized partner with confirmed azoospermia) from the time of study entry to 1 month after the last day of treatment

      Exclusion Criteria:

  • Subjects must not meet any of the following criteria:

    1. Has any ongoing adverse event that could impact tolerability to BXQ-350
    2. Receiving any other non-BXQ-350 study treatment modalities with curative intent, including investigational products other than BXQ-350
    3. Are pregnant or nursing (lactating), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test

Information from the National Library of Medicine

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): NCT04404569


Locations
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United States, Kentucky
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536
United States, Ohio
University of Cincinnati Barrett Center
Cincinnati, Ohio, United States, 45219
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Bexion Pharmaceuticals, Inc.
CTI Clinical Trial and Consulting Services
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Responsible Party: Bexion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04404569    
Other Study ID Numbers: BXQ-350.AE
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bexion Pharmaceuticals, Inc.:
High-grade Glioma
Glioblastoma
Solid Tumor