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ATR Kinase Inhibitor

Adavosertib + Radiation Therapy for Pediatric Brain Tumor

Phase 1
Waitlist Available
Led By Sabine Mueller
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial studies the side effects and best dose of a drug given with local radiation therapy to treat children with a certain type of brain tumor.

Who is the study for?
This trial is for children with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs). They must not have had previous cancer treatments except dexamethasone or surgery, and should have a certain level of blood counts and organ function. Children who can't swallow capsules, have uncontrolled infections, recent major surgeries, or heart diseases aren't eligible.Check my eligibility
What is being tested?
The trial tests the combination of adavosertib with local radiation therapy to see if it's more effective than radiation alone in treating DIPGs. Adavosertib blocks enzymes that tumor cells need to grow. The best dose and side effects are also studied.See study design
What are the potential side effects?
Possible side effects include reactions related to cell growth inhibition which may affect normal cells as well as tumor cells leading to low blood counts, digestive issues, fatigue, and potential risks associated with radiation such as skin irritation and damage to nearby healthy tissue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Time Concentration Curve of Adavosertib
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose of Adavosertib
Number of Dose Limiting Toxicity With Adavosertib
Secondary outcome measures
Change in Expression of p-HH3 of Adavosertib
Change in Expression of ɤ(Gamma)-H2AX of Adavosertib
Change in p-CDC2 of Adavosertib
+3 more
Other outcome measures
Change in p-CDC2, p-HH3 and gamma-H2AX expression
Pharmacokinetic (PK) parameters of adavosertib
Response rate (partial response, complete response, or stable disease)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (adavosertib, radiation therapy)Experimental Treatment4 Interventions
Patients undergo radiation therapy 5 days a week for 6 weeks (up to 30 fractions). Patients also receive adavosertib PO on days 1-5 of weeks 1, 3, and 5; days 1-5 of weeks 1, 3, and 5 AND days 1, 3, and 5 of weeks 2, 4, and 6; OR days 1-5 of weeks 1-6 depending on dose level assignment. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Adavosertib
2015
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,107 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,779 Patients Enrolled for Gliosarcoma
Sabine MuellerPrincipal InvestigatorCOG Phase I Consortium
2 Previous Clinical Trials
128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
2013. "Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01922076.
~4 spots leftby Apr 2025
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