Study of Olutasidenib and Temozolomide in HGG

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Rigel Pharmaceuticals
Study ID
NCT06161974
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Astrocytoma
  • Astrocytoma, Grade III
  • Astrocytoma, Grade IV
  • Diffuse Intrinsic Pontine Glioma
  • Diffuse Midline Glioma, H3 K27M-Mutant
  • High Grade Glioma
  • IDH1 Mutation
  • IDH1 R132
  • IDH1 R132C
  • IDH1 R132G
  • IDH1 R132H
  • IDH1 R132L
  • IDH1 R132S
  • Metastatic Brain Tumor
  • Oligodendroglioma
  • Spinal Tumor
  • Thalamus Tumor
  • WHO Grade III Glioma
  • WHO Grade IV Glioma

Eligibility Criteria

Sex
ALL
Age
12 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Olutasidenib + TMZ — DRUG
    Olutasidenib 150 mg PO BID + Temozolomide 200 mg/m2 PO QD

Study Details

The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.

Key Dates

Start date
Mar 31, 2025
Status verified
Feb 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2035

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum A
    Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3.
  • Experimental: Stratum B
    Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4.
  • Experimental: Stratum C
    Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG.

Primary Outcome Measure

Establish the RP2D of Olutasidenib and Temozolomide (Feasibility cohort) [ Time Frame: Completion of cycle 1 (28 days) for 6-24 patients ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Dorris Kathleen, MD
[email protected]
720-777-8314
Children's National Medical CenterWashington D.C.District of Columbia20010
Eugene M Hwang, MD
[email protected]
202-476-5046
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Ashley O Plant, MD
[email protected]
3122274090
Susan ChiBostonMassachusetts02215
Susan Chi, MD
[email protected]
617-632-4386
Duke University Health SystemDurhamNorth Carolina27708
David H Ashley, MD
[email protected]
919-681-3824
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Peter M de Blank, MD
[email protected]
5135172068
Nationwide Children's HospitalColumbusOhio43235
Maryam Fouladi, MD, MSc
[email protected]
614-722-5758
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Michael J Fisher, MD
[email protected]
215-590-5188
Texas Children's HospitalHoustonTexas77030
Patricia Baxter, MD
[email protected]
832-824-4681
Seattle Children's HospitalSeattleWashington98105
Sarah Leary, MD
[email protected]
206-987-2106

Find similar trials in Aurora, CO

By condition
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By specialty
OncologyNeuro-oncology
By research site
Children's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILSusan Chi· Boston, MADuke University Health System· Durham, NCCincinnati Children's Hospital Medical Center· Cincinnati, OH

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