← Back to Search

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
Select...
I am between 1 and 24 years old.
Select...
I received my last chemotherapy dose more than 3 weeks ago.
Select...
I am between 1 and 24 years old.
Select...
My medulloblastoma has come back or is not responding to treatment.
Select...
My medulloblastoma has come back or is not responding to treatment.
Select...
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:
Select...
I have a history of serious heart disease or abnormal heart rhythm.
Select...
I have been treated with a CHK1 inhibitor before.
Select...
I am currently breastfeeding.
Select...
I have a history of serious heart disease that is not under control.

Timeline

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
Gemcitabine
2017
Completed Phase 3
~1920
filgrastim
1997
Completed Phase 3
~7260

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,466,363 Total Patients Enrolled
2 Trials studying Medulloblastoma
72 Patients Enrolled for Medulloblastoma
St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,323,430 Total Patients Enrolled
13 Trials studying Medulloblastoma
2,875 Patients Enrolled for Medulloblastoma
Giles W. Robinson, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
3 Previous Clinical Trials
320 Total Patients Enrolled
2 Trials studying Medulloblastoma
188 Patients Enrolled for Medulloblastoma

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04023669 — Phase 1
Medulloblastoma Research Study Groups: A: prexasertib + cyclophosphamide, B: prexasertib + gemcitabine
Medulloblastoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04023669 — Phase 1
Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04023669 — Phase 1
~3 spots leftby Dec 2025