A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
Public ClinicalTrials.gov record NCT04421378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Study of Selinexor in Combination With Standard of Care (SoC) Therapy for Newly Diagnosed or Recurrent Glioblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04421378
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 74 participants
Conditions and interventions
Conditions
Interventions
- Selinexor Drug
- Temozolomide (TMZ) Drug
- Lomustine (CCNU) Drug
- Standard Fractionated Radiation therapy (RT) Radiation
- Bevacizumab Drug
- TTField Device
- Carmustine Drug
Drug · Radiation · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 7, 2020
- Primary completion
- Jul 2, 2023
- Completion
- Jul 2, 2023
- Last update posted
- Dec 15, 2024
2020 – 2023
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| University of Southern California (USC Norris Comprehensive Cancer Center and LAC+USC Medical Center) | Los Angeles | California | 90033 | — |
| University of California | San Francisco | California | 94122 | — |
| Baptist Hospital of Miami Cancer Institute, 8900 North Kendall Drive | Miami | Florida | 33176 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Hackensack Meridian Health, 92 Second Street | Hackensack | New Jersey | 07601 | — |
| Atlantic Health Systems Hospital Corp. | Morristown | New Jersey | 07960 | — |
| Northwell Health | Lake Success | New York | 11042 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Lenox Hill Hospital-Northwell Health | New York | New York | 10075 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Utah - Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| University of Washington - Alvord Brain Tumor Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04421378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 15, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04421378 live on ClinicalTrials.gov.