Actively Recruiting
A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
Led by National Cancer Institute (NCI) · Updated on 2026-05-01
96
Participants Needed
1
Research Sites
480 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have diffuse glioma, WHO grades 2-4, confirmed by pathology.
- Mutation in IDH1 or IDH2 genes confirmed by DNA sequencing.
- Participants must have recurrent disease confirmed by biopsy or imaging.
- Prior treatment with radiation, conventional chemotherapy, or vorasidenib before disease progression.
- Participants who had prior surgical resection are eligible for certain study groups.
- Age must be greater than 15 years.
- Karnofsky performance status must be 70% or higher.
- Adequate organ and marrow function including leukocytes ≥3,000/microliter, ANC ≥1,500/microliter, platelets >100,000/microliter, total bilirubin ≤2x ULN except Gilbert Syndrome, AST <3x ULN, ALT <3x ULN, serum creatinine <1.5 mg/dL, and creatinine clearance >60 cc/min.
- Recovery from prior therapy side effects to grade 2 or less.
- Individuals of child-bearing potential and men must agree to use effective contraception during and 3 months after treatment.
- Breastfeeding participants must agree to stop breastfeeding from treatment start until 3 months after treatment ends.
- Participants in surgical cohort must be scheduled for brain tumor biopsy or resection at NIH.
- Ability and willingness to sign informed consent (no legal representative consent allowed).
You will not qualify if you...
- More than one relapse for initial WHO grade 3-4 diagnosis or more than two relapses for WHO grade 2 in Phase II; no relapse limit for Phase I.
- Prior treatment with investigational agents or cytotoxic therapy within 28 days before starting study.
- Vincristine within 14 days before treatment.
- Nitrosoureas within 42 days before treatment.
- Procarbazine within 21 days before treatment.
- Non-cytotoxic agents like interferon, tamoxifen, thalidomide, or cis-retinoic acid within 7 days before treatment.
- Surgery within 14 days before treatment.
- Radiation therapy within 30 days before treatment.
- Prior use of bevacizumab for tumor treatment (except for symptom management).
- Prolonged QTc interval over 470 ms on ECG.
- Prior invasive cancers within 3 years except certain localized or in situ cancers.
- History of allergic reactions to compounds similar to zotiraciclib.
- Pregnancy confirmed by test at screening.
- Uncontrolled illness or social situations limiting study compliance.
- Uncontrolled primary diabetes mellitus.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI NOB Referral Group
CONTACT
J
Jing Wu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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