Bayesian Optimal Interval Design: A Simple and Well-Performing Design for Phase I Oncology Trials.
Ying Yuan, Kenneth R Hess, Susan G Hilsenbeck...
https://pubmed.ncbi.nlm.nih.gov/27407096Actively Recruiting
Phase 1
Phase 2
Age: 15Years +
All Genders
ID05588141
A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With IDH1 or IDH2 Mutations
Led by National Cancer Institute (NCI) · Updated on 2026-06-08
96
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Diffuse gliomas are tumors affecting the brain and spinal cord, especially aggressive in people with mutations in the IDH1 or IDH2 genes. This trial evaluates zotiraciclib, a study drug being tested for effectiveness in people aged 15 and older with recurrent diffuse gliomas that have these gene mutations. The research includes a phase I/II design to assess safety, dosing, and how well the drug works compared to existing data. Participants will take zotiraciclib capsules by mouth on specific days (1, 4, 8, 11, 15, and 18) during 28-day treatment cycles, for up to 18 cycles. Dose levels may be adjusted based on tolerance, and some participants undergoing surgery will receive a single pre-treatment dose before tumor biopsy or removal. The study includes different groups, including dose escalation, recommended dose estimation, and a surgical cohort. Before joining, participants will have physical exams, blood and urine tests, heart function tests, and brain MRIs. They will keep medication diaries to track dosing. Clinic visits occur about once a month for exams and tests, with brain MRI scans every 8 weeks. Researchers will monitor progression-free survival over 12 months and evaluate safety and longer-term outcomes. Total participation may last up to 1.5 years or 18 treatment cycles.
CONDITIONS
Brief 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
Age: 15Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participants must have diffuse glioma, WHO grades 2-4, confirmed by pathology
- IDH1 or IDH2 mutation status confirmed by DNA sequencing
- Recurrent disease proven by histology or imaging
- Prior treatment with radiation, chemotherapy, or vorasidenib
- Age 15 years or older
- Karnofsky performance status 70% or higher
- Adequate organ and marrow function as defined by specific blood count and chemistry levels
- Recovery from prior therapy side effects to grade 2 or less
- Use of highly effective contraception for individuals of child-bearing potential and men
- Willingness to discontinue breastfeeding during and up to 3 months after treatment
- Scheduled for brain tumor biopsy or surgical resection if enrolling in surgical cohort
- Ability to understand and sign informed consent personally
You will not qualify if you...
- More than one relapse for WHO grade 3-4 or more than two relapses for WHO grade 2 in Phase II
- Recent use of investigational agents or certain chemotherapies within specified timeframes before treatment
- Surgery within 14 days before treatment start
- Radiation therapy within 30 days before treatment start
- Prior use of bevacizumab for tumor treatment (except symptom management)
- Prolonged QTc interval over 470ms on ECG
- Prior invasive cancers within 3 years (excluding certain skin and localized cancers)
- Allergic reactions to compounds similar to zotiraciclib
- Pregnancy
- Uncontrolled illnesses or social situations limiting study compliance
- Uncontrolled primary diabetes mellitus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 18 cycles of 28 days each
Participants receive zotiraciclib orally on days 1, 4, 8, 11, 15, and 18 of each 28-day cycle for up to 18 cycles. Participants in the surgical cohort receive one dose before brain tumor biopsy or resection, followed by treatment after recovery.
Multiple visits on dosing days every cycle
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
N
NCI NOB Referral Group
J
Jing Wu, M.D.
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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Published Research Related To This Trial
Accelerated progression of IDH mutant glioma after first recurrence.
Julie J Miller, Franziska Loebel, Tareq A Juratli...
https://pubmed.ncbi.nlm.nih.gov/30668823Phase I Study of Zotiraciclib in Combination with Temozolomide for Patients with Recurrent High-grade Astrocytomas.
Jing Wu, Ying Yuan, Debra A Long Priel...
https://pubmed.ncbi.nlm.nih.gov/33785481Exploiting the therapeutic vulnerability of IDH-mutant gliomas with zotiraciclib.
Ying Pang, Qi Li, Zach Sergi...
https://pubmed.ncbi.nlm.nih.gov/40241769Exploiting the therapeutic vulnerability of IDH-mutant gliomas with zotiraciclib.
Ying Pang, Qi Li, Zach Sergi...
https://pubmed.ncbi.nlm.nih.gov/37786680