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Continued BXQ-350 Treatment for Cancer (ETERNITI Trial)
Phase 1
Waitlist Available
Research Sponsored by Bexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of bxq-350 treatment completion until time of death from any cause; up to approximately 5 years
Awards & highlights
ETERNITI Trial Summary
This trial is for people who were already in other trials for BXQ-350. If they want, they can continue getting the treatment.
Who is the study for?
This trial is for patients who've completed or are still in a BXQ-350 study by Bexion. They must have followed the original study's treatment plan without disqualification, not be pregnant or nursing, and agree to use effective contraception. The doctor must believe more BXQ-350 could help them.Check my eligibility
What is being tested?
The trial offers continued access to BXQ-350 for those previously involved in its studies. It's voluntary and allows participants who benefited from or are benefiting from the drug to keep receiving it after their initial trial ends.See study design
What are the potential side effects?
Specific side effects aren't listed here, but individuals can only continue if they haven't experienced adverse events that would make further treatment with BXQ-350 intolerable.
ETERNITI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of bxq-350 treatment completion until time of death from any cause; up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of bxq-350 treatment completion until time of death from any cause; up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of subjects with clinical benefit
Secondary outcome measures
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
Overall Survival
Time to Disease Progression
ETERNITI Trial Design
1Treatment groups
Experimental Treatment
Group I: Continued TreatmentExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
BXQ-350
2016
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Bexion Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
332 Total Patients Enrolled
CTI Clinical Trial and Consulting ServicesOTHER
34 Previous Clinical Trials
3,685 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any other treatments for my condition besides BXQ-350.I agree to use effective birth control or abstain from sex during and 1 month after the study.I have health issues that may affect my reaction to BXQ-350 treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Continued Treatment
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has BXQ-350 been greenlit by the Food and Drug Administration yet?
"BXQ-350's safety is assessed to be a 1 since this phase 1 trial only has limited evidence suggesting its effectiveness and security."
Answered by AI
Is it still possible to join this medical investigation?
"Clinicaltrials.gov confirms that this clinical study, which was posted on June 8th 2020 and last updated July 18th 2022 is currently not recruiting patients. Nevertheless, there are still 2380 other trials actively seeking candidates right now."
Answered by AI
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