[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"astrocytoma-idh-mutant-grade-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:astrocytoma-idh-mutant-grade-2":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100462580","phase-3-sigma-safusidenib-in-idh1-mutant-glioma-maintenance-100462580",false,"NCT05303519","SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)","A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","SIGMA","Key Inclusion Criteria for Part 1:\n\n1. Patient must be ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Patient must have histologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing.\n3. The IDH mutation, and other applicable gene\u002Fmolecular alterations (see Table 10-2) are determined by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified\u002FCollege of American Pathologists (CAP)-accredited or locally equivalent clinical laboratories. Prior clinical pathology report fulfilling the diagnosis criteria prior to screening with tumor samples collected is acceptable for patient enrollment in both Part 1 and Part 2.\n4. Patient has received no more than 2 prior therapies for disease recurrence\u002Fprogression.\n5. Patient has disease recurrence or progression or cannot tolerate the most recent therapy.\n6. Patient must have a measurable lesion(s) as per the RANO-HGG criteria for primarily enhancing lesions or RANO-LGG criteria for primarily non-enhancing lesions. The lesion (s) must be visible on 2 or more axial slices and have perpendicular diameters of at least 10 × 10 mm. The definition of primarily enhancing lesions or primarily non-enhancing lesions is referred to Section 8.3.1.\n\nKey Inclusion Criteria for Part 2 and 3:\n\n1. Must be ≥18 years old at the time of signing the ICF.\n2. Must agree to submit sufficient tumor tissue for retrospective biomarker and histological analyses. This requirement may be waived in rare circumstances with approval by the Sponsor.\n3. Has adequate hematologic and organ function\n\nKey Inclusion Criteria for Part 2:\n\n1. Diagnosis of histologically confirmed IDH1-mutant Grade 2, Grade 3 with high risk features or Grade 4 astrocytoma, per WHO 2021 classification and Investigator Assessment.\n2. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS). CDKN2A\u002FB status and at least 1 of the following must be confirmed: absence of 1p19q co-deletion by fluorescence in situ hybridization, array comparative genomic hybridization, or NGS; presence of an ATRX loss of function mutation by NGS; or loss of normal ATRX expression by IHC. A validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory must be used for all of the aforementioned results. Documentation of biomarker status, including redacted molecular pathology and NGS reports, must be provided during Screening.\n3. Must not have experienced tumor recurrence or progression between first day of radiotherapy and randomization by local assessment per RANO 2.0.\n4. Participants must have completed radiation therapy with a minimum of 80% of planned treatment completed (with or without concurrent temozolomide) and between 6 and 12 cycles of adjuvant . Randomization must occur at least 28 days and not more than 75 days after the final dose of temozolomide.\n\nKey Inclusion Criteria for Part 3:\n\n1. Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days and no longer than 5 years before the date of enrollment, have not had any other prior anticancer therapy, including chemotherapy and radiotherapy, and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.\n2. Have histologically confirmed Grade 3 IDH-mutant oligodendroglioma according to WHO 2021 criteria per local assessment.\n3. Have residual or recurrent measurable disease per RANO 2.0 and confirmed by BICR, at the time of enrollment.\n4. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL). The presence of 1p19q co-deletion must also be confirmed. All results must be generated using a validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory.\n\nKey Exclusion Criteria for Part 1:\n\n1. Prior anti-cancer therapy, within the applicable periods shown below, before the start of the protocol treatment:\n2. Systemic drug therapies: within 3 weeks (lomustine within 6 weeks)\n3. Surgery: within 3 weeks\n4. Radiation therapy: within 12 weeks\n5. Investigational agents: within 5 half-lives for other investigational agents\n6. Patient did receive the prior therapy targeted to IDH1 mutation..\n7. Known hypersensitivity to safusidenib or to any drug with similar chemical structure or to any other excipient present in the pharmaceutical form of safusidenib.\n\nKey Exclusion Criteria for Part 2 and 3:\n\n1. Participants with prior or anticipated treatment with anti-angiogenic agents such as Avastin (bevacizumab), agents known to target IDH1 or IDH2, or investigational agents for glioma are excluded.\n2. Have brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.\n3. Significant functional or neurocognitive deficits, including uncontrolled seizures, that would preclude participation in protocol-defined study activities, as assessed by Investigator.\n4. Evidence of diffuse leptomeningeal disease.\n5. History of significant cardiac disease within 12 months prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n6. If taking corticosteroids, must be on a stable or decreasing dose for the 14 days prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n7. Participants with other malignancies must have received curative treatment and been disease-free for at least 3 years. Curatively resected skin cancer or curatively treated carcinoma in situ is allowed.\n8. Have a condition that would interfere with, or increase the risk of, study participation.\n\nKey Exclusion Criteria for Part 2 1. Participants may not have received any anticancer treatments other than surgery, radiation, concurrent\u002Fadjuvant temozolomide, and tumor-treating fields. Tumor-treating fields must be discontinued prior to randomization.\n\nKey Exclusion Criteria for Part 3:\n\n1\\. Participants may not have received any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including radiotherapy.","ALL","18 Years",{"count":20,"type":21},365,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent\u002Fprogressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.\n\nThe purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.\n\nThe purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.",[27,28,29,30,31,32,33,34],"Glioma","Astrocytoma, Grade IV","IDH1-mutant Glioma","Astrocytoma, IDH-Mutant, Grade 3","Astrocytoma, IDH-Mutant, Grade 4","Astrocytoma, IDH-Mutant, Grade 2","Oligodendroglioma","Oligodendroglioma, IDH-Mutant and 1p\u002F19q-Codeleted",[36,37,38],"safusidenib","IDH1-mutant glioma","astrocytoma","RECRUITING","2026-06-29",{"date":42,"type":43},"2026-07-01","ACTUAL",{"date":45,"type":43},"2023-06-05",{"date":47,"type":21},"2030-12-01",{"name":49,"class":50},"Nuvation Bio Inc.","INDUSTRY",57,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100582229","phase-1-testing-the-addition-of-an-anti-cancer-drug-triapine-to-the-usual-radiation-therapy-for-recurrent-glioblastoma-or-astrocytoma-100582229","NCT06860594","Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma","A Phase I Trial Combining Triapine With Radiation Therapy for Recurrent Glioblastoma or Astrocytoma","Inclusion Criteria:\n\n* Patients must have histologically, molecularly, or cytologically confirmed recurrent astrocytic tumors including:\n\n  * GBM or variants, IDH-wildtype, grade 2-4 (standard curative measures available or not)\n  * Astrocytoma, IDH-mutant, grade 2-4 (standard curative measures available or not)\n  * Diffuse midline gliomas, including pediatric-type H3 G34 or E3 K27 mutant tumors.\n* Tumors ≤ 6 cm in maximal diameter.\n\n  * Patients who had recent resection for recurrent tumor must have measurable disease.\n* Patients must have at least a 6-month break from last dose of radiation therapy.\n\nRe-irradiation within 6 months may increase risk for radiation necrosis\u002Fedema, which will affect toxicity assessment and patient safety. Additionally, GBM and other high-grade astrocytic tumors can exhibit pseudo-progression within 6 months from completing definitive, 1st line radiation therapy, and re-irradiation during this period will increase risk for misattribution of effect.\n\n* Prior history of standard dose radiation for gliomas of 59.4-60 gray (Gy) in 1.8-2 Gy per fraction (or equivalent or lower) is allowed.\n* Patients who received non-standard radiation dose regimen (e.g., 40 Gy, 34-35 Gy, 25 Gy) or stereotactic radiosurgery are eligible as long as there is at least one of the following:\n\n  * A new tumor outside the original radiotherapy field as determined by the investigator.\n  * There is histologic confirmation of tumor on biopsy or resection.\n  * Imaging findings are consistent with true progressive disease (on standard MRI sequences, MRI spectroscopy\u002Fperfusion, or nuclear medicine imaging).\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of triapine in patients \\\u003C 18 years of age, children are excluded from this study.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).\n* Absolute neutrophil count ≥ 1,500\u002FmcL.\n* Hemoglobin ≥ 8 g\u002FdL.\n* Platelets ≥ 100,000\u002FmcL.\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional ULN.\n* Creatinine ≤ 1.5 x ULN OR glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better.\n* Patients must be able to swallow whole capsules.\n* Patients must be able to undergo MRIs with contrast. Patients with non-compatible devices with MRI can be eligible if CT scans of sufficient quality are obtained. However, patients without non-compatible devices may not use CT scans to meet this requirement.\n* The effects of triapine on the developing human fetus are unknown. For this reason and because ribonucleotide reductase (RNR) inhibitor agent and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 12 months after finishing study treatment. People of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 2 weeks of registration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after completion of triapine administration.\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia.\n* Patients who are receiving any other investigational agents.\n* Patients who are actively taking medications that are known to induce methemoglobinemia (e.g. sulfonamides, nitrofurans, anti-malarials \\[primaquine, chloroquine\\], cyclophosphamide, and ifosfamide).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine.\n* Patients with known G6PD deficiency. Testing for G6PD deficiency is not required.\n* Patients with uncontrolled intercurrent illness, active infections, or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.\n* Pregnant women are excluded from this study because triapine is a RNR inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine, breastfeeding should be discontinued if the mother is treated with triapine. These potential risks may also apply to the radiation used in this study.",{"count":60,"type":21},30,[62],"PHASE1","This phase I trial tests the safety, side effects, and best dose of triapine in combination with radiation therapy in treating patients with glioblastoma or astrocytoma that has come back after a period of improvement (recurrent). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving triapine in combination with radiation therapy may be safe, tolerable, and\u002For effective in treating patients with recurrent glioblastoma or astrocytoma.",[32,65,66,67,68,69,70],"Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant","Recurrent Adult Diffuse Midline Glioma, H3 K27-Mutant","Recurrent Astrocytoma, IDH-Mutant","Recurrent Astrocytoma, IDH-Mutant, Grade 3","Recurrent Astrocytoma, IDH-Mutant, Grade 4","Recurrent Glioblastoma, IDH-Wildtype","2026-06-27",{"date":73,"type":43},"2026-06-30",{"date":75,"type":43},"2025-07-30",{"date":77,"type":21},"2027-06-30",{"name":79,"class":80},"National Cancer Institute (NCI)","NIH",43]