Clinical trial NCT04404569: Continued Treatment for Participants Enrolled in Studies of BXQ-350
Official title: An Open-Label, Multi-Center, Rollover Study to Provide Continued Treatment Access for Participants Enrolled in Studies of BXQ-350
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Keywords: High-grade Glioma
Glioblastoma
Solid Tumor
Lead sponsor: Bexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CTI Clinical Trial and Consulting Services
First posted: 2020-05-27
Enrollment: 5
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility 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

Primary outcomes:
measure: Percentage of subjects with clinical benefit
timeFrame: Day 1 up to approximately 5 years
Secondary outcomes:
measure: Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
timeFrame: Day 1 up to approximately 5 years
measure: Time to Disease Progression
timeFrame: 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
measure: Overall Survival
timeFrame: From date of BXQ-350 treatment completion until time of death from any cause; up to approximately 5 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
city: Cincinnati
country: United States
facility: University of Cincinnati Barrett Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
References: