Elimusertib for Relapse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Relapse+14 More
Elimusertib - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Relapse
  • Lymphoma
  • Recurrent Alveolar Rhabdomyosarcoma
  • recurrent Ewing's Sarcoma
  • Recurrent Malignant Solid Neoplasm
  • Alveolar rhabdomyosarcoma
  • Refractory Ewing Sarcoma
  • Refractory Lymphomas
  • Malignant Neoplasms

Treatment Effectiveness

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Up to 60 months

Up to 28 days
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)
Change in phosphorylated (p)ATR of BAY 1895344 (elimusertib)
Day 28
Frequency of cycle 1 dose limiting toxicities for BAY 1895344 (elimusertib)
Maximum tolerated dose
Up to 60 months
Analysis of biomarkers
Incidence of adverse events
Incidence of adverse events of BAY 1895344 (elimusertib)
Pharmacokinetic (PK) parameters
Response of BAY 1895344 (elimusertib)
Response rate (Phase2)

Trial Safety

Trial Design

1 Treatment Group

Treatment (elimusertib)
1 of 1
Experimental Treatment

23 Total Participants · 1 Treatment Group

Primary Treatment: Elimusertib · No Placebo Group · Phase 1 & 2

Treatment (elimusertib)
Drug
Experimental Group · 1 Intervention: Elimusertib · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 months

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,989 Previous Clinical Trials
41,299,035 Total Patients Enrolled
Michael V OrtizPrincipal InvestigatorPediatric Early Phase Clinical Trial Network

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between 12 months and 18 years of age.
You are between 12 months and 30 years of age.
You must have a minimum body surface area (BSA) > 0.74 m^2.
You have the ability to swallow BAY 1895344 (elimusertib) tablets intact.
You have a solid tumor that is refractory to treatment.
You have a solid tumor that is a Ewing sarcoma or EWS-fusion positive solid tumor.
You have a diagnosis of alveolar rhabdomyosarcoma (ARMS) with the PAX3-FOXO1 fusion
You have a non-CNS primary solid tumor with inactivating alterations of any of the DNA damage repair (DDR) genes.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.