Study on Elimusertib for Treating Solid Tumors That Have Returned or Are Resistant to Treatment
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT05071209
This clinical trial is exploring the safety and effectiveness of a new drug, elimusertib, for patients with solid tumors that have either come back after treatment or are not responding to current treatments. The study aims to find the best dose and see if elimusertib can help stop tumor growth by blocking certain enzymes.
Patient Parameters
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Program Overview
This study is testing a new drug called elimusertib to see if it is safe and effective for treating solid tumors that have returned or are resistant to treatment. Elimusertib works by blocking enzymes that help tumor cells grow. The trial will determine the best dose and evaluate how well the drug works in shrinking tumors in children and young adults.
Description
The study is divided into two parts: Phase I and Phase II. In Phase I, researchers will find the highest dose of elimusertib that patients can safely take. In Phase II, they will see how well the drug works in treating specific types of cancer in children and young adults.
Participants will take elimusertib as a tablet twice a day for three days, followed by a four-day break. This cycle repeats every 28 days for up to 26 cycles, as long as the cancer does not progress and side effects are manageable.
The study will also look at how elimusertib is processed in the body and its effects on cancer cells. Researchers will collect tissue samples to study changes in the cancer before and after treatment.
After finishing the treatment, participants will have follow-up visits every three months for the first year, every six months for the next two years, and then annually for up to five years.
Eligibility Criteria
Inclusion Criteria
- Children and young adults aged 12 months to 30 years, depending on the specific part of the study.
- Must have a body surface area of at least 0.74 m².
- Able to swallow tablets whole.
- Have solid tumors that have returned or are resistant to treatment, with specific genetic changes.
- Must have measurable or evaluable disease.
- No current evidence of active disease in the central nervous system.
- Must be in good overall health with a performance status score of 0, 1, or 2.
- Must have recovered from previous cancer treatments and meet specific timeframes since last treatment.
- Must have adequate blood counts and organ function.
- Must not have received prior treatment with elimusertib or similar drugs.
Exclusion Criteria
- Pregnant or breastfeeding women cannot participate.
- Must not be taking corticosteroids unless on a stable dose for at least seven days.
- Cannot be taking other investigational drugs or anti-cancer agents.
- Cannot be taking drugs that affect the liver enzyme CYP3A4.
- Cannot have active central nervous system metastases.
- Cannot have uncontrolled infections.
- Cannot have had a solid organ transplant.
- Must be able to comply with study requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Children's Hospital of Orange County | 92868 | Orange | California |
| UCSF Medical Center-Mission Bay | 94158 | San Francisco | California |
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
| Children's National Medical Center | 20010 | Washington D.C. | District of Columbia |
| Johns Hopkins All Children's Hospital | 33701 | St. Petersburg | Florida |
| Lurie Children's Hospital-Chicago | 60611 | Chicago | Illinois |
| Riley Hospital for Children | 46202 | Indianapolis | Indiana |
| Johns Hopkins University/Sidney Kimmel Cancer Center | 21287 | Baltimore | Maryland |
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