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 : July 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: BXQ-350||Phase 1|
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.)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2023|
|Estimated Study Completion Date :||July 2023|
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.
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
- 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.
- 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
- 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.
- 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.
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
|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|