21 Participants Needed

Prexasertib + Chemotherapy for Brain Cancer

TE
Overseen ByTabatha E. Doyle, RN
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: St. Jude Children's Research Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

SJELIOT is a phase 1 trial that aims to explore the combination of prexasertib with established DNA-damaging agents used in medulloblastoma to evaluate tolerance and pharmacokinetics in recurrent or refractory disease. Additionally, a small expansion cohort will be incorporated into the trial at the combination MTD/RP2D (maximum tolerated dose/recommended phase two dose) to detect a preliminary efficacy signal.Stratum A: Prexasertib and CyclophosphamidePrimary Objectives* To determine the safety and tolerability and estimate the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of combination treatment with prexasertib and cyclophosphamide in participants with recurrent/refractory Group 3 and Group 4 medulloblastoma and recurrent/refractory sonic hedgehog (SHH) medulloblastoma.* To characterize the pharmacokinetics of prexasertib in combination with cyclophosphamide.Secondary Objectives* To estimate the rate and duration of objective response and progression free survival (PFS) associated with prexasertib and cyclophosphamide treatment in this patient population.* To characterize the pharmacokinetics of cyclophosphamide and metabolites.Stratum B: Prexasertib and GemcitabinePrimary Objectives* To determine the safety and tolerability and estimate the MTD/RP2D of combination treatment with prexasertib and gemcitabine in participants with recurrent/refractory Group 3 and Group 4 medulloblastoma.* To characterize the pharmacokinetics of prexasertib in combination with gemcitabine.Secondary Objectives* To estimate the rate and duration of objective response and PFS associated with prexasertib and gemcitabine treatment in this patient population.* To characterize the pharmacokinetics of gemcitabine and gemcitabine triphosphate (only at St. Jude Children's Research Hospital).

Who Is on the Research Team?

Dr. Giles W. Robinson, MD | Memphis, TN ...

Giles Robinson, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants of childbearing or child fathering potential must be willing to use medically acceptable form of birth control during treatment and for 16 weeks after stopping treatment
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.
See 11 more

Exclusion Criteria

I have a history of serious heart disease or abnormal heart rhythm.
I do not have any serious health issues that could affect my participation in the study.
You have a history of a heart condition that causes a specific type of heart rhythm problem.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combination treatment with prexasertib and either cyclophosphamide or gemcitabine in 28-day cycles

Up to 24 months
Weekly visits during the first cycle, regular intervals thereafter

Dose-limiting toxicity evaluation

Evaluation of dose-limiting toxicity during the first cycle until day 1 of cycle 2

28 days
At least weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year after treatment completion

What Are the Treatments Tested in This Trial?

Interventions

  • Cyclophosphamide
  • Gemcitabine
  • Prexasertib
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: B: prexasertib + gemcitabineExperimental Treatment4 Interventions
Group II: A: prexasertib + cyclophosphamideExperimental Treatment4 Interventions

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Cytoxan for:
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Approved in European Union as Endoxan for:
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Approved in Canada as Neosar for:
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Approved in Japan as Endoxan for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials
451
Recruited
5,326,000+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

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