Phase 2 Brain Cancer Trial, Recruiting NCT05859334 Sponsor: National Cancer Institute (NCI) Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT05859334
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be 18 years of age or older
  • You must have a type of brain tumor called an IDH-wildtype glioma (grade 2, 3, or 4), confirmed by a tissue sample test
  • Your tumor must have a specific genetic change called an FGFR-TACC gene fusion, found through an approved genetic test
  • Your brain tumor must have come back or gotten worse after at least one previous treatment, such as surgery, radiation, or chemotherapy
  • Your tumor must be measurable on an MRI scan taken before treatment begins
  • You must be well enough to carry out basic daily activities (your doctor will assess this using a standard scale)
  • Your blood counts must meet minimum levels: enough white blood cells, red blood cells, and platelets (confirm with trial site)
  • Your liver must be working well enough, based on blood test results
  • Your kidneys must be working at least at a minimum level, based on a blood test
  • Your blood phosphate level must be within the normal range (treatment to correct this is allowed)
  • You must have recovered from any serious side effects of previous surgery, radiation, or chemotherapy
  • If you have HIV, you must be on effective treatment with an undetectable level of virus in the last 6 months
  • If you have chronic hepatitis B, the virus must be undetectable while on treatment
  • If you have had hepatitis C, you must have been successfully treated and cured, or currently be on treatment with an undetectable viral load
  • Your heart must be functioning at a certain level, as assessed by your doctor (confirm with trial site)
  • If you are able to become pregnant, or if you are a man whose partner could become pregnant, you must agree to use effective contraception during the study and for one month after finishing the study drug
  • You must be willing and able to give written consent to take part; a legal representative may do this on your behalf if needed

Who may not be able to join:

  • You are currently taking part in another clinical trial involving an experimental treatment
  • You have had a serious allergic reaction to a drug similar to the study drug (erdafitinib)
  • You are taking certain medications that interfere with how the study drug works in the body (your doctor will check your current medications — confirm with trial site)
  • You have another illness that is not well controlled
  • You are currently pregnant, as the study drug may harm an unborn baby
  • You are currently breastfeeding
  • You have a current eye condition affecting the retina, such as central serous retinopathy or retinal pigment epithelial detachment
  • You have an abnormal heart rhythm reading on an ECG, specifically a prolonged QTc interval (over 480 milliseconds)
  • You have previously been treated with a drug that targets the FGFR pathway (the same type of drug as the study drug)

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
4 January 2024
Est. completion
23 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective response rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov