Status:
TERMINATED
Continued Treatment for Participants Enrolled in Studies of BXQ-350
Lead Sponsor:
Bexion Pharmaceuticals, Inc.
Collaborating Sponsors:
CTI Clinical Trial and Consulting Services
Conditions:
Neoplasms
Eligibility:
All Genders
1+ years
Phase:
PHASE1
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 stil...
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 requ...
Eligibility Criteria
Inclusion
- Each subject must meet the following criteria:
- 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
- Has completed the End of Study visit of the prior Bexion-sponsored BXQ-350 clinical study
- Did not meet any treatment discontinuation criteria of the original prior Bexion- sponsored BXQ-350 clinical study
- Investigator opinion indicates that continued treatment with BXQ-350 is clinically appropriate for the subject
- 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)
- 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)
- 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
- Subjects must not meet any of the following criteria:
- Has any ongoing adverse event that could impact tolerability to BXQ-350
- Receiving any other non-BXQ-350 study treatment modalities with curative intent, including investigational products other than BXQ-350
- 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
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04404569
Start Date
June 8 2020
End Date
September 23 2024
Last Update
December 20 2024
Active Locations (3)
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1
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536
2
University of Cincinnati Barrett Center
Cincinnati, Ohio, United States, 45219
3
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210