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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 is a Phase 1 study that was terminated before completion, run by Karyopharm Therapeutics. The registered enrollment target is 74 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04421378
The ClinicalTrials.gov registry entry for NCT04421378 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karyopharm Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT04421378 reports 0 study locations.
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.
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