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Anti-tumor agent

Stratum B for Astrocytoma

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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rigel PharmaceuticalsLead Sponsor

31 Previous Clinical Trials

3,788 Total Patients Enrolled

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,443 Total Patients Enrolled

3 Trials studying Astrocytoma

565 Patients Enrolled for Astrocytoma

Maryam Fouladi, MDStudy ChairNationwide Children's Hospital

11 Previous Clinical Trials

2,405 Total Patients Enrolled

3 Trials studying Astrocytoma

565 Patients Enrolled for Astrocytoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives are researchers hoping to accomplish with this clinical trial?

"This trial, to be evaluated over a predetermined cycle of 28 days for between 6-12 patients, seeks to evaluate Progression-Free Survival (PFS) in Grade 3 IDH1 mutant Astrocytomas. Secondary goals include the assessment of health related quality of life outcomes with PROMIS survey systems which measure frequencies and levels of autonomy on scales ranging from 1(minimum) through 5 (maximum). Additionally, this study will assess Overall Survival (OS) in IDH1 mutant Grade 3 Astrocytoma as well as PFS in IDH1 mutant Grade 4 Astrocytoma compared to historical controls matched by molecular strat"

Answered by AI

What is the degree of risk associated with Stratum B?

"Although no efficacy data exists, there have been some studies which indicate that Stratum B is relatively safe for use. As a result, our team has attributed it with an assessment rating of 2 on the 1-3 scale."

Answered by AI

Are participants being enrolled in this research currently?

"Referencing clinicaltrials.gov, this experiment is not presently in the process of patient recruitment. It was originally posted on June 15th 2024 and most recently updated on November 30th 2023; however, there are 863 other trials that are actively searching for volunteers at present."

Answered by AI

Who has the opportunity to take part in this research?

"To take part in this clinical trial, candidates must be aged between 12 months and 39 years old with a confirmed brain tumor. 65 participants are planned for the duration of the study."

Answered by AI

Does this medical trial accept participants aged 20 or above?

"According to the trial's inclusion criteria, eligible participants must fall between 12 months and 39 years of age."

Answered by AI

Are there multiple locations in North America conducting this research endeavor?

"This trial is taking place at 18 different clinical sites, ranging from the Princess Máxima Center in Utrecht to Susan Chi in Boston. Other notable locations include Duke University Health System in Durham and a multitude of other institutions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Olutasidenib and Temozolomide in HGG

2024. "Study of Olutasidenib and Temozolomide in HGG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161974.

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