Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a primary brain or spinal cord (central nervous system) tumour, confirmed by a pathology report, that fits one of the specific tumour types listed for each study group (cohort).
• People in the Phase I group: those with any primary brain or spinal cord tumour that has come back or is growing again, regardless of its genetic features.
• People in the Phase IIA group: those newly diagnosed with a type of brain tumour called ependymoma that has a genetic change called MYCN amplification, and who have already completed surgery and radiation therapy.
• People in the Phase IIB group: those with MYCN-amplified ependymoma that has come back or is growing, or those with a brain tumour called medulloblastoma that has come back and has MYC or MYCN amplification.
• People in the Phase IIC group: those with any other primary brain or spinal cord tumour that has come back or is growing, and has MYC or MYCN amplification.
• People in the Phase IID group: those with any recurrent glioblastoma (a type of brain tumour) that does not have MYC or MYCN amplification.
• People who have saved tumour tissue samples (either a tissue block or 15 specially preserved slides) available for testing by the research team.
• People in the Phase IIA group who finished radiation therapy at least 4 weeks but no more than 10 weeks before starting the trial treatment.
• People in all other groups who finished their most recent chemotherapy or radiation at least 4 weeks before starting the trial treatment (longer waiting periods apply depending on which specific treatments were previously used — confirm with trial site).
• People aged 18 years or older.
• People who are functioning fairly independently day-to-day, as measured by a standard assessment scale (Karnofsky score of 70% or above); people with significant leg weakness who can still mostly care for themselves may also be considered eligible.
• People whose blood counts and organ function (including kidneys, liver, and bone marrow) meet the specific healthy ranges required by the trial.
• People who are able to use effective contraception during the trial and for a set period after the last dose of the study drug (6 months for women who could become pregnant; 3 months for those who could father a child).
• People who are breastfeeding and willing to stop breastfeeding from the start of treatment until 6 months after the last dose.
• People who are able to report their own symptoms and physical functioning, as assessed by the clinical team at screening.
• People who are able to understand and are willing to sign a written consent form.

Who may not be able to join:

• People who have had allergic reactions to substances chemically similar to the study drug PLX038.
• People who have had major surgery within 2 weeks before starting the trial treatment (major surgery means an operation where a body cavity such as the chest, abdomen, or the space around the brain or spinal cord was opened).
• People who need to take certain medications that strongly interact with specific enzymes (CYP3A or UGT1A1) during the trial treatment period (confirm with trial site which medications apply).
• People who have previously been treated with a specific class of chemotherapy drugs called pegylated topoisomerase inhibitors.
• People who have had significant digestive system problems (grade 2 or higher) caused by a specific type of radiation treatment called PHOTON craniospinal irradiation.
• People who have a specific inherited genetic variation (homozygous UGT1A1*28) that severely reduces the body's ability to process certain drugs.
• People who test positive for HIV, Hepatitis C, or Hepatitis B.
• People who are pregnant (confirmed by a pregnancy test at screening).
• People who are unable to have MRI scans.
• People with another current or previous cancer, unless that cancer or its treatment is unlikely to affect the safety or results of this trial (confirm with trial site).
• People with other serious, uncontrolled health conditions that would make it difficult to participate fully in the trial.

Important: Always verify eligibility with the trial site directly before applying.