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NCT04216329 · ClinicalTrials.gov registry record · Phase 1
Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma
A Phase 1 study of Glioblastoma and Gliosarcoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT04216329: Active Phase 1 study of Glioblastoma and Gliosarcoma, sponsored by National Cancer Institute (NCI).
NCT04216329 is a Phase 1 study of Glioblastoma and Gliosarcoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04216329, a Phase 1 study of Glioblastoma and Gliosarcoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Glioblastoma is a type of brain cancer. Treatments include radiation, chemotherapy, and surgery. But survival rates are poor. Researchers think that the drug selinexor, when combined with chemotherapy and radiation, might help. Objective: To learn the highest dose of selinexor that people with brain cancer can tolerate when given with temozolomide and radiation therapy. Eligibility: People ages 18 and older with brain cancer that has not been treated with chemotherapy or radiation. Design: Participants will be screened under another protocol. Before participants start treatment, they will have tests: Neurological and physical evaluations Blood and urine tests Possible computed tomography (CT) scan or magnetic resonance imaging (MRI) of the brain if they have not had one in 3 weeks. Participants will lie in a machine that takes pictures of the body. They may have a dye injected into a vein. Surveys about their well-being Participants will have radiation to the brain for up to 6 weeks. This will usually be given once a day, Monday through Friday. Starting the second day of radiation, participants will take selinexor by mouth once a week. They will take it in weeks 1, 2, 4, and 5. The timing may be changed. Starting the first day of radiation, participants will take temozolomide by mouth once a day until they complete radiation. Participants will have blood tests once per week during treatment. Participants will have a follow-up visit 1 month after they complete treatment. Then they will have visits at least every 2 months for the first 2 years, then at least every 3 months for another year. Visits will include MRIs and blood tests.
Primary Outcome
The MTD is the dose level at which no more than 1 of up to 6 participants experience dose limiting-toxicity (DLT) within 1 month of completion of treatment, and the dose below that at which at least 2 (of\< =6) participants have DLT as a result of selinexor/radiation therapy (RT)/temozolomide.
Conditions Studied
Interventions
- DRUG Selinexor
- DRUG Temozolomide
- RADIATION Generic Radiation therapy (RT)
- OTHER Selective serotonin receptor (5-HT3) antagonists
- OTHER Olanzapine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-07-07 |
| Est. Completion | 2028-07-30 |
| Phase | Phase 1 |
What the registry record for NCT04216329 still lists
NCT04216329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Selinexor is the first listed.
NCT04216329 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04216329 about?
NCT04216329 is a clinical study titled "Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma". Background: Glioblastoma is a type of brain cancer. Treatments include radiation, chemotherapy, and surgery. But survival rates are poor. Researchers think that the drug selinexor, when combined with chemotherapy and radiation, might help. Objective: To learn the highest dose of selinexor that pe...
What is the current status of trial NCT04216329?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2020-07-07. Estimated completion is 2028-07-30.
What conditions does trial NCT04216329 study?
This clinical trial studies the following conditions: Glioblastoma, Gliosarcoma, Newly Diagnosed.
What interventions are being tested in trial NCT04216329?
The interventions under investigation include: Selinexor (DRUG), Temozolomide (DRUG), Generic Radiation therapy (RT) (RADIATION), Selective serotonin receptor (5-HT3) antagonists (OTHER), Olanzapine (OTHER).
Who is sponsoring clinical trial NCT04216329?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04216329 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04216329's enrollment target sits among peer trials
11 188th of 199 higher than 12 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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.
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