Phase 2 Brain Cancer Trial, Recruiting NCT05432804 Sponsor: National Cancer Institute (NCI) Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT05432804
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 have been diagnosed with a specific type of brain tumor called glioblastoma (with particular molecular features: IDH wild-type and MGMT promoter methylated), confirmed by a tissue sample, and the tumor has come back for the first time and been surgically removed or biopsied.
  • Before your surgery or biopsy, scans showed at least one measurable tumor that was clearly visible and large enough to be measured in two directions (at least 10mm each way).
  • You previously received the standard first treatment for glioblastoma, which includes chemotherapy with temozolomide combined with radiation therapy.
  • You have not received any other treatment for the recurrent tumor beyond surgery or biopsy.
  • You are 18 years of age or older.
  • You are well enough to carry out most daily activities (a doctor will assess this using a standard scale).
  • Your blood counts are at healthy enough levels — including white blood cells, platelets, and hemoglobin (confirm with trial site).
  • Your liver and kidney function are within acceptable ranges (confirm with trial site).
  • If you are living with HIV, you are on effective treatment and your virus levels are undetectable within the past 6 months.
  • If you have or have had hepatitis B, your virus levels must be undetectable while on appropriate treatment.
  • If you have had hepatitis C, you must have been successfully treated and cured, or currently be on treatment with undetectable virus levels.
  • If you have or have had another type of cancer, you may still be eligible as long as it is unlikely to interfere with this trial's treatment or results.
  • If you have a history of heart problems or have received treatments that affect the heart, your heart function must meet a minimum standard on a recognised heart health scale (confirm with trial site).
  • You are willing and able to use effective contraception during the study and for a set period after treatment ends (180 days for women; 90 days for men), because the study drugs may harm an unborn baby.
  • You are able to understand and sign a consent form, or have a legal representative who can do so on your behalf.

Who may not be able to join:

  • Your body has not fully recovered from side effects of previous chemotherapy.
  • You still have significant side effects (above a minor level) from any previous cancer treatment, apart from hair loss.
  • You are currently taking part in another clinical trial involving an experimental treatment.
  • You have previously been treated with a drug called bevacizumab.
  • You have had a serious allergic reaction to drugs chemically similar to selinexor or temozolomide (the two study drugs).
  • You have had a hypersensitivity reaction to a drug called dacarbazine, as it is processed by the body in a similar way to temozolomide.
  • You have another serious illness that is not currently under control.
  • You are pregnant, as the study drugs could harm an unborn baby.
  • You are breastfeeding, as the study drugs may pass to a nursing infant; breastfeeding is not allowed during treatment and for 7 days after the last dose.
  • You are hospitalised with severe COVID-19 and are aged 75 or older, or have certain high-risk indicators identified by specific medical tests (confirm with trial site).

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 9 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
20 March 2023
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Recommended phase 2 dose (RP2D) (Phase I); Progression-free survival (PFS) (Phase II)

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: 9 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