Continued Treatment for Participants Enrolled in Studies of BXQ-350
Key facts
- Who runs it
- Bexion Pharmaceuticals, Inc.
- Where
- Cincinnati, Columbus, and Lexington, United StatesSee the 3 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 1
- People taking part
- 5 people enrolled
- Started
- 8 Jun 2020
- Ended
- 23 Sept 2024
- Type of study
- Interventional
- Treatments tested
- BXQ-350
- Record updated
- 20 December 2024
- Why it stopped
- Bexion Pharmaceuticals no longer has open studies in which subjects would be eligible to rollover and continue treatment under the BXQ-350.AE protocol. Therefore, no additional subjects will be enrolled in this trial.
Who can take part
- Age
- 1 year and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
- University of Cincinnati Barrett CenterCincinnati, United States
- The Ohio State University Comprehensive Cancer CenterColumbus, United States
- University of Kentucky/Markey Cancer CenterLexington, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Continued TreatmentTreatment being tested
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.
Treatment: BXQ-350
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Open-Label, Multi-Center, Rollover Study to Provide Continued Treatment Access for Participants Enrolled in Studies of BXQ-350
- Record updated
- 20 December 2024