Study on Zotiraciclib for Recurrent Brain Tumors with IDH1 or IDH2 Mutations

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05588141

Provider View

This clinical trial is testing a new drug, zotiraciclib, to see if it can help treat brain tumors called gliomas that have returned after treatment and have specific gene mutations (IDH1 or IDH2).

Patient Parameters

Program Overview

Diffuse gliomas are brain and spinal cord tumors that can be very aggressive, especially when they have certain gene mutations (IDH1 or IDH2). This study aims to find out if a new drug, zotiraciclib, can be effective for people with these types of tumors that have come back after treatment. Participants must be 18 years or older and have gliomas with these specific mutations. They will undergo various tests, including physical exams, blood and urine tests, heart function tests, and brain MRIs. Zotiraciclib is taken as a capsule at home on specific days of a 28-day cycle. Participants will keep a diary of their medication intake and visit the clinic monthly for check-ups. The study may last up to 18 cycles, or about 1.5 years.

Description

Zotiraciclib is a new drug being studied for its potential to treat brain tumors called gliomas, which are difficult to treat, especially when they have specific gene mutations (IDH1 or IDH2). This drug works by targeting certain processes in the cancer cells, and it is taken as a capsule. The study is divided into two phases: Phase I will determine the best dose of zotiraciclib, and Phase II will evaluate how well the drug works in keeping the cancer from progressing for 12 months. Participants will take the drug on specific days of a 28-day cycle, and the dose may be adjusted based on how well it is tolerated. Some participants may also undergo surgery as part of the study. The study will include up to 64 participants, and they will be closely monitored for safety and effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a type of brain tumor called diffuse glioma, confirmed by lab tests, and have specific gene mutations (IDH1 or IDH2).
  • Must have had previous treatment like radiation or chemotherapy and have tumors that have come back.
  • Must be 15 years or older and in good overall health.
  • Must have good organ function and blood counts.
  • Must agree to use effective birth control during the study and for three months after.
  • Must be willing to stop breastfeeding during the study and for three months after.
  • Must be scheduled for a brain tumor biopsy or surgery if in the surgical group.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • More than one previous relapse for high-grade tumors or more than two for lower-grade tumors (for Phase II only).
  • Recent use of certain cancer treatments or surgeries before starting the study.
  • History of severe allergic reactions to similar drugs.
  • Pregnant or breastfeeding women.
  • Uncontrolled health conditions that could interfere with the study.

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