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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 belowSelect...
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:Select...
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
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 moreSecondary 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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious heart disease or abnormal heart rhythm.I am between 1 and 24 years old.You must have a disease that can be measured or assessed according to the study's rules.I do not have any serious health issues that could affect my participation in the study.My last radiation treatment was over 4 weeks ago.I received my last chemotherapy dose more than 3 weeks ago.I can understand and am willing to sign the consent form.I am between 1 and 24 years old.I can do most activities and am expected to live at least 6 more weeks.My bone marrow and organs are functioning well.My medulloblastoma has come back or is not responding to treatment.You have a history of a heart condition that causes a specific type of heart rhythm problem.I have been treated with a CHK1 inhibitor before.Your heart's pumping function is below a certain level according to specific heart tests.I am currently breastfeeding.My medulloblastoma has come back or is not responding to treatment.You have a history of prolonged QTc interval (a heart rhythm issue).I have a history of serious heart disease that is not under control.I have been on a stable or decreasing dose of corticosteroids for at least a week.I am of childbearing age and have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: A: prexasertib + cyclophosphamide
- Group 2: B: prexasertib + gemcitabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.