High Grade Glioma study: Olutasidenib + TMZ
Official title Study of Olutasidenib and Temozolomide in HGG
ClinicalTrials.gov ID: NCT06161974
What this study is testing
What is Olutasidenib + Temozolomide?
An investigational oral drug combination being studied for newly diagnosed high‑grade glioma with an IDH1 mutation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the drug combination can extend survival in patients with IDH‑mutant high‑grade glioma.
- Who it's for
- Newly diagnosed pediatric or young adult patients with a high‑grade glioma that has an IDH1 mutation.
- What's involved
- Participants will receive the study drug olutasidenib together with the chemotherapy drug temozolomide, and will attend scheduled clinic visits and undergo routine tests.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 39
You may be able to join if
- Criteria TarGeT-D study strata definitions
- Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3.
- Stratum B: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4.
- Stratum C: Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG.
- Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible.
You likely can't join if
- Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.
- Progesterone-only hormonal contraception associated with inhibition of ovulation.
- Intra Uterine Device (IUD).
- Intra uterine hormone releasing system.
- Bilateral tubal occlusion.
- Vasectomized partner.
See the full eligibility criteria
- Criteria TarGeT-D study strata definitions
- Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3.
- Stratum B: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4.
- Stratum C: Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG.
- Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible. All patients must have tumor tissue from diagnostic biopsy or resection, without exceptions.
- For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, and histopathology consistent with diffuse WHO Grade 2-4 glioma.
- All other HGG must be WHO Grade 3 or 4. 1.3) Disease status: There are no disease status requirements for enrollment
- Measurable disease is not required. Patients without measurable disease are eligible.
- Primary spinal tumor: Patients with a primary spinal HGG are eligible.
- Patient must not have metastatic disease.
- R132H, R132C, R132S, R132G or R132L.
- Patients whose tumors harbor other alterations in addition to IDH1 mutation will potentially be eligible following consensus recommendation by the international multidisciplinary molecular screening committee.
- Patients with IDH2 mutations are not eligible.
- Patients with oligodendroglioma, IDH-mutant and 1p/19q-codeleted are not eligible. 2.2 Weight: Patients must weigh ≥35 Kg (77 lbs) at the time of enrollment on TarGeT-D.
- Patients in pre-maintenance phase must enroll and start treatment no later than 21 calendar days post-completion of RT.
- Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3.
- Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
- Hemoglobin \> 8 g/dL (may be transfused). 2.5.2 Adequate Renal Function Defined as
- Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR
- Total bilirubin must be ≤ 1.5 × institutional ULN.
- AST(SGOT)/ALT(SGPT) \< 3 × institutional ULN.
- Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not a strong inducer or inhibitor of CYP3A4/5.
- Patients must be able to swallow oral medications to be eligible for study enrollment. 2.6. Informed consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent.
- Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.
- Progesterone-only hormonal contraception associated with inhibition of ovulation.
- Intra Uterine Device (IUD).
- Intra uterine hormone releasing system.
- Bilateral tubal occlusion.
- Vasectomized partner.
- Sexual abstinence (avoiding heterosexual intercourse).
- Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation.
- Male or female condom with or without spermicide.
- Cap, diaphragm, or sponge with spermicide.
- Corticosteroids: Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.
- Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.
- Anti-cancer Agents: Concurrent anti-cancer agents are not allowed with the exception of temozolomide given concurrently with RT and as protocol-instructed post RT maintenance therapy after enrollment on TarGeT-D.
- Anticonvulsants: Patients who are receiving enzyme inducing anticonvulsants that are strong inducers of CYP3A4/5 are not eligible.
- Strong CYP3A4/5 inducers: Patients who are receiving strong inducers of CYP3A4/5 are not eligible.
- Patients who are receiving medications known to prolong QTc interval are not eligible
- Selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft) should be used with caution but are...
- Other Criteria
- Infection: Patients who have an uncontrolled infection are not eligible.
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.
- Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.
- Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible.
- Patients with prior or ongoing clinically significant illness, medical or psychiatric condition, that, in the investigator's opinion, could affect the safety of the participant, or could impair the assessment of study...
- Patients with any prior solid organ transplant are not eligible.
- Patients with secondary/radiation-related HGG are not eligible.
- Patients with metastatic/disseminated HGG who have received CSI are not eligible.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- Chicago, Illinois, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Seattle, Washington, United States
- Randwick, New South Wales, Australia
- Perth, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States; Chicago, Illinois, United States; Durham, North Carolina, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States; Seattle, Washington, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.