Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Placebo Administration for Recurrent Glioblastoma, IDH-Wildtype

This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent). Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE).

Official registry: https://clinicaltrials.gov/study/NCT05432804 · National Cancer Institute (NCI) · enrollment listed as 97

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Magnetic Resonance Imaging, or Placebo Administration. The registry lists allocation as randomized. This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent).

They plan to enroll about 97 people at 39 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Phase 1 and Randomized Phase 2 Trial of Selinexor and Temozolomide in Recurrent Glioblastoma

Interventions: Biospecimen Collection, Magnetic Resonance Imaging, Placebo Administration, Selinexor, Temozolomide

Primary outcome (registry wording): Recommended phase 2 dose (RP2D) (Phase I)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Prior to resection or biopsy, patients must have measurable disease, defined as at least one bi-dimensional contrast-enhancing lesion with clearly defined margins, with 2 perpendicular diameters of at least 10 mm, visible on \>= 2 axial slices
  • Patients must have received first-line treatment of temozolomide plus radiotherapy
  • Patients must not have received any prior therapy aside from resection or biopsy for their recurrent disease
  • Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of selinexor (KPT-330) in combination with temozolomide in patients \< 18 years of age, children are excluded from this study
  • Karnofsky performance status \>= 60% (Eastern Cooperative Oncology Group \[ECOG\] =\< 2)
  • Absolute neutrophil count \>= 1,500/mcL
  • Platelets \>= 100,000/mcL

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

39 listed

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FAQ about this NCT record

Is NCT05432804 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05432804?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05432804?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary