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Alkylating Agent

Prexasertib + Chemotherapy for Brain Cancer

Phase 1

Waitlist Available

Led By Giles W. Robinson, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

Participant must be ≥1 year and <25 years of age at time of screening

Participant must have received their last dose of myelosuppressive anticancer chemotherapy at least 3 weeks prior to study enrollment

Must not have

Participant with a history of clinically significant, uncontrolled heart disease and/or repolarization abnormalities as documented by a standard 12-lead ECG

Previous exposure to any CHK1 inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years from diagnosis

Awards & highlights

No Placebo-Only Group

Summary

This trial is a phase 1 trial that will study the combination of prexasertib with two established DNA-damaging agents, cyclophosphamide and gemcitabine, to treat patients with recurrent or refractory medulloblastoma. The goal is to evaluate the safety and tolerability of this combination therapy and to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D). Additionally, a small expansion cohort will be treated at the MTD/RP2D to assess preliminary efficacy.

Who is the study for?

This trial is for children and adolescents aged 1 to less than 25 with recurrent or stubborn Group 3/Group 4 or SHH medulloblastoma brain tumors. They should have measurable disease, be at least three weeks out from chemotherapy, four weeks from radiation, and not on increasing steroids. Participants need a certain level of physical ability and life expectancy, as well as proper organ function. Pregnant women can't join; those who can have kids must use birth control.

What is being tested?

The SJELIOT phase 1 trial tests prexasertib combined with cyclophosphamide (Stratum A) or gemcitabine (Stratum B) in young patients with tough-to-treat brain tumors. It aims to find the safest dose that works and understand how the body processes these drugs while looking for early signs of effectiveness.

What are the potential side effects?

Possible side effects include reactions related to bone marrow suppression like anemia and increased risk of infection due to low white blood cell counts, nausea, vomiting, hair loss from cyclophosphamide; plus fatigue and liver issues could occur with both drug combinations.

Eligibility Criteria

Inclusion Criteria

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

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I am between 1 and 24 years old.

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I received my last chemotherapy dose more than 3 weeks ago.

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I am between 1 and 24 years old.

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My medulloblastoma has come back or is not responding to treatment.

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My medulloblastoma has come back or is not responding to treatment.

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I am of childbearing age and have a negative pregnancy test.

Exclusion Criteria

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

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I have a history of serious heart disease or abnormal heart rhythm.

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I have been treated with a CHK1 inhibitor before.

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I am currently breastfeeding.

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I have a history of serious heart disease that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years from diagnosis

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years from diagnosis

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from diagnosis for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Estimate the Maximum tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) of each doublet by stratum

To characterize the area under the concentration-time curve (AUC0-∞) of prexasertib in combination with cyclophosphamide or gemcitabine.

To characterize the systemic clearance (CL) of prexasertib in combination with cyclophosphamide or gemcitabine.

+1 more

Secondary study objectives

Duration of objective response by stratum

Progression-free survival for patients treated with prexasertib and cyclophosphamide or gemcitabine

Rate of objective response (complete or partial response) by stratum

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: B: prexasertib + gemcitabineExperimental Treatment4 Interventions

Stratum B: Participants receive combination treatment with gemcitabine given intravenously (IV) on days 1 and 15 and prexasertib given intravenously (IV) on days 2 and 16. Cycles repeat every 28 days for up to 24 months (26 cycles) in the absence of disease progression or unacceptable toxicity. They may also receive growth therapy support with filgrastim or peg-filgrastim. Note: Only if absolutely necessary, gemcitabine may be given on day 16 and prexasertib may be given on day 17.

Group II: A: prexasertib + cyclophosphamideExperimental Treatment4 Interventions

Stratum A: Participants receive combination treatment with cyclophosphamide given intravenously (IV) on days 1 and 15 and prexasertib given intravenously (IV) on days 2 and 16. Cycles repeat every 28 days for up to 24 months (26 cycles) in the absence of disease progression or unacceptable toxicity. They may also receive growth therapy support with filgrastim or peg-filgrastim. Note: Only if absolutely necessary, cyclophosphamide may be given on day 16 and prexasertib may be given on day 17.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Prexasertib

2017

Completed Phase 2

~810