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NCT04421378 · ClinicalTrials.gov registry record · Phase 1
A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
A Phase 1 study, sponsored by Karyopharm Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT04421378: Clinical Trial Phase 1 study, sponsored by Karyopharm Therapeutics.
NCT04421378 is a Phase 1 study that was terminated before completion, run by Karyopharm Therapeutics. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04421378, a Phase 1 study, was terminated before completion, sponsored by Karyopharm Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
This is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion) and a Phase 2 randomized efficacy exploration study and will independently evaluate 3 different combination regimens in 3 treatment arms in patients with nGBM (Arms A and B) or with rGBM (Arm C). * Arm A: evaluating the combination of selinexor with radiation therapy (S-RT) in nGBM participants with uMGMT * Arm B: evaluating the combination of selinexor with radiation therapy and temozolomide (TMZ) (S-TRT) in nGBM participants with methylated-O6-methylguanine-DNA-methyltransferase (mMGMT) * Arm C: evaluating the combination of selinexor with lomustine (or carmustine, if lomustine is not available) (S-L/C) in rGBM participants regardless of MGMT status * Arm D: evaluating the combination of selinexor with bevacizumab in rGBM participants regardless of MGMT status * Arm E: evaluating the combination of selinexor with tumor treating fields (TTField) in rGBM participants regardless of MGMT status
Primary Outcome
MTD was defined as highest dose of selinexor in at which no more than one of six participants experienced a dose-limiting toxicity (DLT). DLT was based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Interventions
- DRUG Bevacizumab
- DRUG Selinexor
- DRUG Temozolomide (TMZ)
- DRUG Lomustine (CCNU)
- RADIATION Standard Fractionated Radiation therapy (RT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2023-07-03 |
| Phase | Phase 1 |
Why NCT04421378 stopped before completion
NCT04421378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT04421378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04421378 about?
NCT04421378 is a clinical study titled "A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma". This is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion) and a Phase 2 randomized e...
What is the current status of trial NCT04421378?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2020-06-08. Estimated completion is 2023-07-03.
What interventions are being tested in trial NCT04421378?
The interventions under investigation include: Bevacizumab (DRUG), Selinexor (DRUG), Temozolomide (TMZ) (DRUG), Lomustine (CCNU) (DRUG), Standard Fractionated Radiation therapy (RT) (RADIATION).
Who is sponsoring clinical trial NCT04421378?
This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04421378's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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