Prexasertib + Irinotecan for Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to test whether the study drug prexasertib is a safe and effective treatment for people with DSRCT or RMS when given in combination with the standard drugs irinotecan and temozolomide. The study will test different doses of prexasertib in combination with irinotecan and temozolomide to find the highest dose of prexasertib that causes few or mild side effects in participants.
Who Is on the Research Team?
Emily Slotkin, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients aged β₯12 months with advanced or metastatic desmoplastic small round cell tumor or rhabdomyosarcoma that's resistant to standard treatments. They must have measurable disease, be in a certain health condition (Karnofsky/Lansky score), and have adequate organ function. Pregnant individuals, those with uncontrolled infections, heart conditions like congestive heart failure, or hypersensitivity to irinotecan are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of Prexasertib in combination with Irinotecan and Temozolomide to determine the recommended phase II dose
Dose Expansion
Participants receive the recommended phase II dose of Prexasertib in combination with Irinotecan and Temozolomide to evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Irinotecan
- Prexasertib
Irinotecan is already approved in United States, European Union, Japan, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor