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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

Must not have

Patients who have a history of Torsades de Pointes, carry a diagnosis of congestive heart failure, or have a family history of prolonged QT syndrome are not eligible

Patients who have an uncontrolled infection are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have any infections that are currently uncontrolled.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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%

Dyspnoea

10%

Infusion related reaction

10%

Cough

10%

Dyspepsia

Hyponatraemia

Abdominal pain lower

Oropharyngeal pain

Non-cardiac chest pain

Pelvic pain

Headache

Nasopharyngitis

Hot flush

Mucosal inflammation

Alanine aminotransferase increased

Blood creatinine increased

Bone pain

Hypertension

Oedema peripheral

Viral infection

Pneumonia

Abdominal distension

Insomnia

Arthralgia

Hypomagnesaemia

Muscle spasms

Pruritus

Flushing

Abdominal pain upper

Ascites

Small intestinal obstruction

Intestinal obstruction

Pleuritic pain

Spinal compression fracture

Gastrointestinal obstruction

Catheter site pain

Biliary dilatation

Duodenal obstruction

Pollakiuria

Urosepsis

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2590