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Protein Kinase Inhibitor

Elimusertib for Solid Cancers

Phase 1 & 2
Waitlist Available
Led By Michael V Ortiz
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with recurrent or refractory solid tumors. Patients must have had histologic verification of malignancy at original diagnosis or relapse
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

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.

Who is the study for?
This trial is for young patients (up to 30 years old) with solid tumors or lymphoma that have returned or are treatment-resistant. They must be able to swallow pills, not currently on other cancer treatments or strong CYP3A4 drugs, and can't have active brain metastases or uncontrolled infections.Check my eligibility
What is being tested?
The trial is testing Elimusertib's safety and optimal dosage in treating relapsed/refractory solid tumors. It aims to see if it can halt tumor growth by blocking enzymes needed for cell proliferation.See study design
What are the potential side effects?
Potential side effects of Elimusertib may include issues related to the nervous system, digestive disturbances, changes in blood counts, liver function alterations, and possibly fatigue due to its mechanism of inhibiting cellular enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has come back or didn't respond to treatment, and was confirmed by a biopsy.
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I can take care of myself but may not be able to do heavy physical work.
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I am between 12 months and 18 years old.
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I am between 12 and 21 years old and eligible for the phase 2 study.
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My bilirubin levels are within the normal range for my age.
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My kidney function, measured by creatinine clearance or GFR, is normal or above 70 mL/min.
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My blood counts meet the required levels and I don't have cancer in my bone marrow.
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My nerve-related side effects from previous treatments are mild.
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I am between 12 months and 30 years old, eligible for phase 2 of the study.
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My body surface area is at least 0.74 square meters.
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I can swallow pills without any issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of cycle 1 dose limiting toxicities for BAY 1895344 (elimusertib)
Response of BAY 1895344 (elimusertib)
Secondary outcome measures
Area under the drug concentration time curve of BAY 1895344 (elimusertib)
Change in pH2AX of BAY 1895344 (elimusertib)
Change in pKAP1 of BAY 1895344 (elimusertib)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (elimusertib)Experimental Treatment1 Intervention
Patients receive elimusertib PO BID on days 1-3, 8-10, 15-17, and 22-24 of each cycle. Treatment repeats every 28 days for 26 cycles in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,603 Previous Clinical Trials
40,913,252 Total Patients Enrolled
1,376 Trials studying Lymphoma
381,561 Patients Enrolled for Lymphoma
Michael V OrtizPrincipal InvestigatorPediatric Early Phase Clinical Trial Network

Media Library

Elimusertib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05071209 — Phase 1 & 2
Lymphoma Research Study Groups: Treatment (elimusertib)
Lymphoma Clinical Trial 2023: Elimusertib Highlights & Side Effects. Trial Name: NCT05071209 — Phase 1 & 2
Elimusertib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05071209 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
~2 spots leftby Jun 2024