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Cyclin-Dependent Kinase Inhibitor
Zotiraciclib for Brain Cancer
Phase 1 & 2
Recruiting
Led By Jing Wu, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial tests a new drug to treat aggressive brain and spinal cord tumors in people with certain gene mutations. Participants will take the drug at home, have clinic visits once a month and undergo tests to evaluate their heart and brain.
Who is the study for?
Adults with recurrent high-grade gliomas and IDH1 or IDH2 mutations can join this trial. They must have had prior treatment, be willing to use contraception, and not be breastfeeding. Participants need good organ function and cannot have had multiple relapses or other recent cancers.Check my eligibility
What is being tested?
The study is testing Zotiraciclib's effectiveness for aggressive brain tumors with specific gene mutations. Patients take the drug orally in cycles, alongside regular clinic visits for exams, heart tests, MRIs, and maintaining a medication diary.See study design
What are the potential side effects?
While specific side effects of Zotiraciclib are not listed here, similar drugs may cause nausea, fatigue, liver issues, diarrhea or constipation. Side effects will likely be monitored through blood tests and physical exams during clinic visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine 12-months progression free survival (PFS) in participants with recurrent glioma, IDH1/2-mutant, WHO grade 3 treated with zotiraciclib in comparison with the established brain tumor database matched for tumor molecular characteristic...
To estimate recommended phase II dose (RP2D) of zotiraciclib
Secondary outcome measures
To determine the efficacy of treatment with zotiraciclib in participants with recurrent glioma, IDH1/2-mutant WHO grade 3 in comparison with the established brain tumor database by 3 years PFS rate
To determine the efficacy of treatment with zotiraciclib in participants with recurrent glioma, IDH1/2-mutant WHO grade 3 in comparison with the established brain tumor database by 5 years overall survival (OS) rate
To determine the safety of zotiraciclib in participants with recurrent glioma, IDH1/2-mutant WHO grades 2-4
Trial Design
3Treatment groups
Experimental Treatment
Group I: 3Experimental Treatment1 Intervention
One RP2D dose of zotiraciclib given on the day prior to brain tumor biopsy or resection, a continuation of treatment with estimated RP2D of zotiraciclib given in 28 days cycles following the recovery of the surgery
Group II: 2Experimental Treatment1 Intervention
Estimated RP2D of zotiraciclib given in 28 day cycles
Group III: 1Experimental Treatment1 Intervention
Escalation/de-escalation dose levels of zotiraciclib given in 28 day cycles
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,345 Total Patients Enrolled
Jing Wu, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
393 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken certain medications recently.I can understand and am willing to sign the consent form myself.I am mostly able to care for myself but may not be able to do active work.I haven't had any other cancers in the last 3 years.My disease has relapsed more than once if it's severe, or more than twice if it's moderate.My diabetes is not under control.I have had treatment like radiation or chemotherapy before my disease got worse.My cancer has come back, confirmed by tests or scans.My brain tumor is a grade 2-4 diffuse glioma, confirmed by pathology.My cancer has an IDH1 or IDH2 mutation confirmed by a specific test.I am breastfeeding but willing to stop from the start of the study until 3 months after it ends.I have recovered from previous cancer treatment side effects.I am scheduled for a brain tumor biopsy or surgery at NIH.I have had surgery to remove a tumor and can join groups 1-4.My blood tests show normal organ function.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
- Group 3: 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any participants being accepted for enrollment in this research project?
"Information on clinicaltrials.gov confirms that this trial, which was initially posted December 7th 2022 and last updated December 1st 2022, is no longer accepting participants. Nonetheless, there are 1190 other studies currently enrolling patients at present time."
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