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New treatment option for High Grade Glioma
Official title Study of Olutasidenib and Temozolomide in HGG
ClinicalTrials.gov ID: NCT06161974
What this study is testing
What is Olutasidenib + TMZ?
Olutasidenib + TMZ is an investigational medicine, being studied as a potential treatment for high grade glioma.
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 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.
- 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.
- already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on: 1.1) Age: patients must be ≥12 years and ≤39 years of...
You likely can't join if
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown potential risks of fetal and...
- 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.
See the full eligibility criteria
Who can join
- 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.
- already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on: 1.1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR 1.2) Diagnosis:
- 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. The diagnosis of HGG, including DIPG, must have...
- 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.
- for assignment to TarGeT-D, for all strata: 2.1 Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here:
- 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. 2.3 Performance Level: Karnofsky ≥ 50% for...
- Patients in pre-maintenance phase must enroll and start treatment no later than 21 calendar days post-completion of RT.
- Patients not in pre-maintenance phase must enroll and start treatment no later than 35 calendar days post-completion of RT. 2.5 Organ Function Requirements 2.5.1 Adequate Bone Marrow Function Defined as:
- 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
- Maximum serum creatinine based on age/gender as follows: 10 to \< 13 yrs=1.2 mg/dL for males and females. 13 to \< 16 yrs=1.5 mg/dL for males and 1.4 mg/dL for females. 2.5.3 Adequate Liver Function Defined as:
- Total bilirubin must be ≤ 1.5 × institutional ULN.
- AST(SGOT)/ALT(SGPT) \< 3 × institutional ULN.
- Alkaline Phosphatase \< 3 × institutional ULN. 2.5.4 Adequate Neurologic Function Defined as:
- 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...
What rules you out
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown potential risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be...
- 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).
- The following contraceptive measures are NOT considered effective:
- 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.
- Using the following types of concomitant medications:
- 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. Strong inducers of CYP3A4/5 should be avoided from 14 days prior to or 5 half-lives (whichever is longer) enrollment to...
- 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. Viral testing is not required unless clinically...
- 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's taking place
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Randwick, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Perth, Western Australia, Australia
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Heidelberg, Baden-Wurttemberg, Germany
- Utrecht, Netherlands
- Auckland, Grafton, New Zealand
- London, United Kingdom
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 - 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?
Study sites include Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Durham, North Carolina, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.