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Elimusertib for Solid Cancers
Study Summary
This trial is testing a new drug to see if it's safe and effective in treating patients with solid tumors that have returned or stopped responding to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have a solid tumor or lymphoma diagnosis, not originating in the brain.My cancer has come back or didn't respond to treatment, and was confirmed by a biopsy.I can take care of myself but may not be able to do heavy physical work.I am not taking medication that strongly affects liver enzyme CYP3A4.I am between 12 months and 18 years old.I am between 12 and 21 years old and eligible for the phase 2 study.I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.My cancer can be measured or seen on tests.I have recovered from side effects of my previous cancer treatments.My bilirubin levels are within the normal range for my age.My kidney function, measured by creatinine clearance or GFR, is normal or above 70 mL/min.My cancer has spread to my brain.My blood counts meet the required levels and I don't have cancer in my bone marrow.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.My nerve-related side effects from previous treatments are mild.I do not have any infections that are currently uncontrolled.I am between 12 months and 30 years old, eligible for phase 2 of the study.My body surface area is at least 0.74 square meters.I can swallow pills without any issues.I have a solid tumor or lymphoma diagnosis, not originating in the brain.
- Group 1: Treatment (elimusertib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
How many participants have been recruited to this clinical research?
"To conduct this trial, 23 qualified individuals are necessary. Eligible patients can join from multiple medical centres such as University of Minnesota/Masonic Cancer Center in Minneapolis, Minnesota and Children's Hospital of Orange County in Orange, California."
Who has the necessary credentials to participate in this research?
"This trial is seeking 23 participants with relapsed cancer, aged between 12 months and 30 years. To be eligible for the study, patients must have a body surface area of at least 0.74 m^2, and the ability to swallow tablets intact. Additionally, applicants must meet one of three criteria: (1) having histological confirmation of any Ewing sarcoma or EWS-fusion positive solid tumor; (2) Alveolar rhabdomyosarcoma with PAX3-FOXO1 fusion; or (3) Non-CNS primary solid tumors including lymphoma that feature inactivating alterations"
Is there an open enrollment period for this clinical experiment?
"Confirmation of this trial's active recruitment status can be found on clinicaltrials.gov, the study having been initially posted on December 3rd 2021 and most recently amended November 19th 2022."
How many venues are actively pursuing this experiment?
"There are 25 different medical sites involved in this clinical trial. Participants can enroll at the renowned University of Minnesota/Masonic Cancer Center, Children's Hospital of Orange County and Duke University Medical Centre, as well as 22 other locations."
Is this trial open to those aged 75 years or younger?
"This medical experiment is open to individuals between 12 months and 30 years of age."
What is the ultimate goal of this trial?
"This trial seeks to assess the frequency of dose-limiting toxicity in patients receiving elimusertib over a 60 month period. Secondary measures include incidence of adverse events, change in pKAP1 levels, and median area under drug concentration time curve (AUC)."
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