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Topoisomerase I inhibitor

Prexasertib + Irinotecan for Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma

Phase 1 & 2

Waitlist Available

Led By Emily Slotkin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine based on age/gender derived from the Schwartz formula for estimating GFR53

Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m2 OR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether prexasertib is a safe and effective treatment for people with DSRCT or RMS when given with irinotecan and temozolomide.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include reactions related to drug infusion, blood disorders due to bone marrow suppression, liver issues reflected by altered enzyme levels, kidney problems indicated by creatinine clearance changes, and possibly cardiac complications as suggested by QT interval measurements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, based on a test result, is appropriate for my age and gender.

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My kidney function is normal or near normal.

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My liver function tests are within acceptable limits, even with liver metastases.

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My cancer can be measured by scans.

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My bone marrow is functioning well.

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I am at least 1 year old.

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It's been over 21 days since my last antibody therapy, and any side effects are mild.

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My cancer is a specific type confirmed by a specialist.

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My current treatment isn't working, and there's no cure known for my condition.

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I can do most activities by myself if I am older than 16, or I can do most activities with help if I am 16 or younger.

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My bilirubin levels are within the normal range for my age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

recommended phase II does of Prexasertib

response

Side effects data

From 2020 Phase 2 trial • 172 Patients • NCT03414047

37%

Anaemia

37%

Nausea

34%

Thrombocytopenia

29%

Fatigue

27%

Neutropenia

27%

Vomiting

27%

Abdominal pain

24%

Asthenia

22%

Decreased appetite

20%

Constipation

17%

Diarrhoea

17%

Platelet count decreased

17%

Pyrexia

15%

Leukopenia

15%

Rash

15%

Back pain

12%

Febrile neutropenia

12%

Pain

12%

Hypokalaemia

12%

Neutrophil count decreased

10%

Infusion related reaction

10%

Cough

10%

Dyspnoea

10%

Dyspepsia

Abdominal pain lower

Non-cardiac chest pain

Hyponatraemia

Pelvic pain

Headache

Nasopharyngitis

Hot flush

Mucosal inflammation

Alanine aminotransferase increased

Blood creatinine increased

Bone pain

Oropharyngeal pain

Hypertension

Oedema peripheral

Pneumonia

Abdominal distension

Viral infection

Insomnia

Arthralgia

Hypomagnesaemia

Muscle spasms

Pruritus

Flushing

Abdominal pain upper

Ascites

Pleuritic pain

Spinal compression fracture

Gastrointestinal obstruction

Catheter site pain

Biliary dilatation

Duodenal obstruction

Pollakiuria

Small intestinal obstruction

Urosepsis

Intestinal obstruction

Mouth ulceration

Dizziness

Myocardial infarction

Gastritis

Obstruction

Neutropenic sepsis

Staphylococcal bacteraemia

Aspartate aminotransferase increased

Weight decreased

White blood cell count decreased

Hypoalbuminaemia

Myalgia

100%

80%

60%

40%

20%

Study treatment Arm

Prexasertib Cohort 3

Prexasertib Cohort 4

Prexasertib Cohort 1

Prexasertib Cohort 2

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prexasertib and IrinotecanExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prexasertib

2017

Completed Phase 2

~810

Irinotecan

2017

Completed Phase 4

~2680

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,599 Total Patients Enrolled

4 Trials studying Desmoplastic Small Round Cell Tumor

344 Patients Enrolled for Desmoplastic Small Round Cell Tumor

Emily Slotkin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

8 Previous Clinical Trials

537 Total Patients Enrolled

4 Trials studying Desmoplastic Small Round Cell Tumor

344 Patients Enrolled for Desmoplastic Small Round Cell Tumor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being included in this clinical trial?

"Although this study is not presently enrolling patients, it was last updated on October 3rd, 2022. People that are looking for similar trials should know that there are currently 75 studies actively recruiting participants with desmoplastic small round cell tumor and 277 Prexasertib trials also enrolling patients."

Answered by AI

Are new participants being sought for this experiment?

"This study is not currently seeking participants, according to the information on clinicaltrials.gov. The study was originally posted on September 17th, 2019, and was last updated on October 3rd, 2022. Although this trial is not recruiting patients at the moment, there are 352 other trials that are actively looking for participants."

Answered by AI

Are there any other recent Prexasertib trials that we can learn from?

"There are currently 277 active clinical trials investigating the efficacy of Prexasertib. Of these, 53 are in Phase 3. The largest proportion of these trials is taking place Woolloongabba, Queensland; however, there are 8677 different locations worldwide where at least one trial is being conducted."

Answered by AI

What is the main reason doctors prescribe Prexasertib?

"Prexasertib is a common treatment for patients with malignant neoplasms of the pancreas. Additionally, this medication can help treat other conditions such as neoplasm metastasis and rhabdomyosarcomas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma

2019. "A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04095221.

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