21 Participants Needed

Prexasertib + Irinotecan for Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma

WT
ES
Overseen ByEmily Slotkin, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 - MSK Pediatric ...

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

absolute neutrophil count (ANC) β‰₯ 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.
See 26 more

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
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of Prexasertib in combination with Irinotecan and Temozolomide to determine the recommended phase II dose

1 year
Every 6-8 weeks for disease scans

Dose Expansion

Participants receive the recommended phase II dose of Prexasertib in combination with Irinotecan and Temozolomide to evaluate safety and efficacy

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Prexasertib and IrinotecanExperimental Treatment2 Interventions

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

πŸ‡ΊπŸ‡Έ
Approved in United States as Camptosar for:
πŸ‡ͺπŸ‡Ί
Approved in European Union as Irinotecan for:
πŸ‡―πŸ‡΅
Approved in Japan as Topotecin for:
πŸ‡¨πŸ‡¦
Approved in Canada as Irinotecan for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security