OncoMatch/Clinical Trials/NCT05588141
A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
Is NCT05588141 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Zotiraciclib for brain tumor.
Treatment: Zotiraciclib — Background: Diffuse gliomas are tumors that affect the brain and spinal cord. Gliomas that develop in people with certain gene mutations (IDH1 or IDH2) are especially aggressive. Better treatments are needed. Objective: To see if a study drug (zotiraciclib) is effective in people with recurrent diffuse gliomas who have IDH1 or IDH2 mutations. Eligibility: People aged 15 years and older with diffuse gliomas that returned after treatment. They must also have mutations in the IDH1 or IDH2 genes. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of their heart function. They will have an MRI of their brain. A new biopsy may be needed if previous results are not available. Zotiraciclib is a capsule taken by mouth with a glass of water. Participants will take the drug at home on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. They may also be given medications to prevent side effects of the study drug. The schedule for taking the study drug may vary for participants who will undergo surgery. Participants will be given a medication diary for each cycle. They will write down the date and time of each dose of the study drug. Participants will visit the clinic about once a month. They will have a physical exam, blood tests, and tests to evaluate their heart function. An MRI of the brain will be repeated every 8 weeks. Participants may remain in the study for up to 18 cycles (1.5 years).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 mutation
Required: IDH2 mutation
Disease stage
Required: Stage WHO GRADE 2, WHO GRADE 3, WHO GRADE 4 (WHO)
WHO grades 2-4
Prior therapy
Must have received: radiation therapy
Participants must have received prior treatment (e.g., radiation, conventional chemotherapy, or vorasidenib) prior to disease progression.
Must have received: cytotoxic chemotherapy
Participants must have received prior treatment (e.g., radiation, conventional chemotherapy, or vorasidenib) prior to disease progression.
Must have received: other targeted therapy (vorasidenib)
Participants must have received prior treatment (e.g., radiation, conventional chemotherapy, or vorasidenib) prior to disease progression.
Cannot have received: investigational agent (IDH mutant inhibitor)
any investigational agent (including IDH mutant inhibitor) and/or standard of care cytotoxic therapy within 28 days prior to treatment initiation
Cannot have received: cytotoxic chemotherapy
any investigational agent (including IDH mutant inhibitor) and/or standard of care cytotoxic therapy within 28 days prior to treatment initiation
Cannot have received: vinca alkaloid (vincristine)
vincristine within 14 days prior to treatment initiation
Cannot have received: alkylating agent (nitrosoureas)
nitrosoureas within 42 days prior to treatment initiation
Cannot have received: alkylating agent (procarbazine)
procarbazine within 21 days prior to treatment initiation
Cannot have received: non-cytotoxic agent (interferon, tamoxifen, thalidomide, cis-retinoic acid)
non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, within 7 days prior to treatment initiation
Cannot have received: surgery
surgery within 14 days prior to treatment initiation
Cannot have received: radiation therapy
radiation therapy within 30 days prior to treatment initiation
Cannot have received: VEGF inhibitor (bevacizumab)
Exception: participants who received bevacizumab for symptom management, including but not limited to cerebral edema, or pseudo progression can be enrolled
bevacizumab for tumor treatment. Note: participants who received bevacizumab for symptom management, including but not limited to cerebral edema, or pseudo progression can be enrolled
Lab requirements
Blood counts
leukocytes >=3,000/microliter; absolute neutrophil count (ANC) >=1,500/microliter; platelets >100,000/microliter
Kidney function
serum creatinine < 1.5 mg/dL; calculated creatinine clearance by CKD-EPI equation > 60 cc/min
Liver function
total bilirubin <=2x ULN (ULN 1.3 mg/dl) except for participants with Gilbert Syndrome; AST < 3x ULN (ULN 34U/L); ALT < 3x ULN (ULN 55U/L)
Cardiac function
Prolonged QTc >470ms as calculated by correction formula on screening electrocardiogram (ECG) (QTCf can be used; QTCb can be used for participants with sinus bradycardia) [excluded]
Participants must have adequate organ and marrow function as defined below: * leukocytes >=3,000/microliter * absolute neutrophil count (ANC) >=1,500/microliter * platelets >100,000/microliter * total bilirubin <=2x ULN (ULN 1.3 mg/dl) except for participants with Gilbert Syndrome * AST < 3x ULN (ULN 34U/L) * ALT < 3x ULN (ULN 55U/L) * serum creatinine < 1.5 mg/dL * calculated creatinine clearance by CKD-EPI equation > 60 cc/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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