Prexasertib + Irinotecan for Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma

Overseen By Emily Slotkin, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Uncontrolled infection, Pregnant, Congestive heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

21 Participants Needed

Trial Summary

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.

Research Team

Emily Slotkin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for patients aged ≥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

absolute neutrophil count (ANC) ≥ 1500/mm^3

I have recovered from side effects of previous cancer treatments, except for hair loss.

My kidney function is normal or near normal.

Exclusion Criteria

Patients with known hypersensitivity to irinotecan or its excipients are not eligible

I do not have a history of heart issues like Torsades de Pointes, congestive heart failure, or family history of prolonged QT syndrome.

Patients for whom the investigator deems that irinotecan and temozolomide are not appropriate are not eligible

Treatment Details

Interventions

• Irinotecan
• Prexasertib

Trial Overview The study tests the safety and effectiveness of prexasertib combined with standard drugs irinotecan and temozolomide in treating specific tumors. It aims to find the highest dose of prexasertib that participants can tolerate with few or mild side effects.

Participant Groups

Group I: Prexasertib and Irinotecan Experimental Treatment 2 Interventions

Patients will have extent of disease scans following every 2 cycles (every 6 weeks on dose levels 0-3, and every 8 weeks on dose level -1 (if required). Patients will be allowed to continue therapy as long as they do not experience dose-limiting toxicities or progression of disease.

Irinotecan is already approved in United States, European Union, Japan, Canada for the following indications:

Approved in United States as Camptosar for:

• Colorectal cancer

Approved in European Union as Irinotecan for:

• Colorectal cancer

Approved in Japan as Topotecin for:

• Colorectal cancer
• Small cell lung cancer

Approved in Canada as Irinotecan for:

• Colorectal cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+