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Anti-tumor agent

Olutasidenib + Temozolomide for Brain Tumors

Phase 2
Waitlist Available
Research Sponsored by Rigel Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene
Must not have
Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible
Patients who are receiving enzyme inducing anticonvulsants that are strong inducers of CYP3A4/5 are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of diagnosis until date of death due to any cause or date of last follow-up, assessed up to 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a drug can extend the life of kids/young adults with a deadly brain tumor linked to a genetic mutation.

Who is the study for?
This trial is for young patients aged between 1 and 39 with a high-grade glioma brain tumor that has an IDH1 mutation. They must have good liver, bone marrow, and kidney function, be able to give informed consent, and not be pregnant or breastfeeding. Patients must agree to use effective contraception if applicable.
What is being tested?
The study tests the effectiveness of olutasidenib combined with temozolomide (TMZ) in extending the lives of patients with IDH-mutant high-grade gliomas. It aims to see if this drug combination can improve survival rates in these young patients.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with cancer treatments like olutasidenib and TMZ may include fatigue, nausea, vomiting, decreased blood cell counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor is newly diagnosed and has an IDH1 mutation.
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My cancer has a specific change in the IDH1 gene.
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I am mostly able to care for myself, regardless of my age.
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My bone marrow is working well.
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I am between 12 months and 39 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a condition that affects how my body absorbs medication.
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I am not taking any strong CYP3A4/5 inducing seizure medications.
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I am not on medications that affect heart rhythm.
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I do not have any infections that are not under control.
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My high-grade glioma is not caused by previous radiation treatment.
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I am not taking medication that strongly activates liver enzymes.
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I have not received CSI for my spread high-grade glioma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of diagnosis until date of death due to any cause or date of last follow-up, assessed up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of diagnosis until date of death due to any cause or date of last follow-up, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess Progression-Free Survival (PFS) in Grade 3 IDH1-mutant Astrocytoma (Stratum A)
Establish the RP2D of Olutasidenib and Temozolomide (Feasibility cohort)
Maximum plasma concentration [Cmax] of Olutasidenib
Secondary study objectives
Assess Progression-Free Survival in IDH1-mutant Grade 4 Astrocytoma (Stratum B)
Evaluate Health-Related Quality of Life Outcomes (All Strata)
Evaluate Overall Survival in IDH1-mutant Grade 3 Astrocytoma (Stratum A)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Stratum CExperimental Treatment1 Intervention
Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG.
Group II: Stratum BExperimental Treatment1 Intervention
Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4.
Group III: Stratum AExperimental Treatment1 Intervention
Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3.

Find a Location

Who is running the clinical trial?

Rigel PharmaceuticalsLead Sponsor
35 Previous Clinical Trials
3,932 Total Patients Enrolled
Nationwide Children's HospitalOTHER
348 Previous Clinical Trials
5,228,009 Total Patients Enrolled
7 Trials studying Diffuse Intrinsic Pontine Glioma
829 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Maryam Fouladi, MDStudy ChairNationwide Children's Hospital
11 Previous Clinical Trials
2,405 Total Patients Enrolled
8 Trials studying Diffuse Intrinsic Pontine Glioma
2,291 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
~40 spots leftby Jun 2029
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