Phase 1 Brain Cancer Trial, Recruiting NCT05521984 Sponsor: Washington University School of Medicine Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT05521984
Recruiting Phase 1

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:

  • People who have been diagnosed with a primary brain tumor that has come back, where no curative treatment is available, OR a solid tumor that has returned or stopped responding to treatment, where no curative option exists and at least two lines of prior treatment have been tried.
  • People whose tumor can be measured using standard medical imaging criteria (specific measurement criteria apply depending on whether the tumor is in the brain or elsewhere in the body — confirm with trial site).
  • People who are expected to live for more than 12 weeks.
  • People who have previously been treated with radiation, chemotherapy, or a combination of both.
  • People who are between 6 and 29 years old (inclusive).
  • People who are able to swallow whole pills.
  • People whose blood counts and organ function fall within acceptable ranges, as assessed by blood tests (confirm specific values with trial site).
  • People with a performance score of 60 or higher on standard medical scales, meaning they are able to carry out some daily activities (confirm with trial site).
  • People of childbearing potential, and their partners, who are willing to use two forms of contraception (including at least one barrier method) throughout the study period, and who agree to immediately inform their treating doctor if pregnancy occurs or is suspected.
  • People, or their parents or legal guardians, who are able to understand and willing to sign a formal consent document approved by an ethics review board.

Who may not be able to join:

  • People who are currently using, or have previously used, a class of diabetes medications called SGLT2 inhibitors or thiazolidinediones.
  • People currently taking high-dose dexamethasone (a steroid) at more than 4 mg per day, or who have not been on a stable or reducing dose for at least 7 days before starting the study drug.
  • People with a history of another cancer, unless all treatment for that cancer was completed at least 2 years ago with no sign of return, or the cancer was a locally treated skin cancer of a specific type (confirm with trial site).
  • People with Type 1 diabetes or who are currently receiving insulin treatment.
  • People who have had a stroke or a mini-stroke (transient ischemic attack) within the last 5 years.
  • People with a blood sugar control reading (HbA1c) above 8.5%.
  • People who are currently taking part in another clinical trial involving an experimental treatment.
  • People who have had a significant allergic reaction to medications that are chemically similar to the study drug, dapagliflozin.
  • People with certain uncontrolled health conditions, including active infection, heart failure, unstable chest pain, irregular heart rhythms, poor circulation in the limbs, a dangerous chemical imbalance called ketoacidosis, severe kidney disease, low blood pressure causing symptoms, or frequent urinary tract or yeast infections.
  • People who are pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test within 14 days before starting the study drug.
  • People living with HIV whose immune cell count (CD4+ T-cells) is below 350 cells/mcL, or who have had a serious HIV-related infection within the past 12 months.

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 7 July 2026
Phase 1: approximately ~10% 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.

Contact this trial

Principal Investigator: Andrew Cluster, M.D., Washington University School of Medicine

Phone: 314-273-1451

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
3 April 2023
Est. completion
31 March 2031

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number and type of adverse events experienced by participants

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: 7 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