Phase 2 Brain Cancer Trial, Recruiting NCT07428616 Sponsor: Exelixis Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT07428616
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:

  • People who have been diagnosed with a meningioma (a type of brain tumour) confirmed by tissue testing, specifically World Health Organization (WHO) grade 1, 2, or 3.
  • People whose tumour has come back or continued to grow after standard treatments such as surgery and/or radiation, or who have been assessed as unable to receive those treatments.
  • People who have received at least one course of radiation therapy directed at the meningioma, unless radiation was not medically appropriate for them.
  • People whose tumour has been shown on scans to have grown by more than 15% in two dimensions within the past 6 months, or who have developed new tumour spots.
  • People who had external beam radiation, brachytherapy, or radiosurgery must have finished that treatment at least 24 weeks before starting this trial.
  • People who have measurable tumour activity on scans, assessed within 14 days before starting treatment, as determined by the trial investigator.
  • People who have a performance status score of 60% or higher on the Karnofsky scale, which means they are able to care for themselves and carry out some normal activities (confirm with trial site).
  • People who have adequately functioning organs and bone marrow, confirmed by tests done within 14 days before starting treatment.

Who may not be able to join:

  • People who have ever had a condition called hypertensive encephalopathy (a serious complication of very high blood pressure affecting the brain).
  • People who have tumour growths outside the brain that are pressing into or invading major blood vessels such as the main vein returning blood to the heart, the main artery from the heart, or the lung's main blood vessel.
  • People who are unable to have an MRI scan for any reason.
  • People for whom the treating doctor determines that surgery or radiation is the appropriate next treatment.
  • People who have received cancer-fighting drugs, biological therapies, or other systemic anticancer treatments (including experimental ones) within 4 weeks or 5 half-lives of the drug — whichever period is shorter — before starting the trial.
  • People who have had major surgery within the past 8 weeks, or minor surgery (including brain biopsies) within the past 7 days, and whose surgical wound has not fully healed.
  • People with serious uncontrolled ongoing or recent illnesses, including uncontrolled high blood pressure, certain stomach or bowel conditions with a high risk of tearing or abnormal connections forming, significant recent bleeding (including in the brain), or other serious medical conditions.
  • People who require kidney dialysis (either haemodialysis or peritoneal dialysis).
  • People who have previously received a transplanted solid organ or stem cells from a donor.

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 22 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.

Contact this trial

Principal Investigator: Study Director, Exelixis

Phone: 1-888-EXELIXIS (888-393-5494)

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 2
Sponsor
Exelixis
Registry
ClinicalTrials.gov
Start date
21 May 2026
Est. completion
29 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)

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: 22 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