GliosarcomaPhase 1NCT04216329
Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma
A Phase 1 study testing Selinexor, Temozolomide and Generic Radiation therapy (RT) in people with Gliosarcoma and Newly Diagnosed, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gliosarcoma, Newly Diagnosed, Glioblastoma
- What is being tested?
- Selinexor, Temozolomide and Generic Radiation therapy (RT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 9 Jul 2026
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis
- Pathologically confirmed glioblastoma or gliosarcoma (including astrocytoma, grade IV)
- Patients must be eligible for definitive external beam radiotherapy and temozolomide.
- Age >18 years. Because no dosing or adverse event data are currently available on the use of Selinexor in combination with Temodar in patients <18 years of age, children are excluded from this study.
- Patients should have a Karnofsky performance scale (KPS) greater than or equal to 70
- Absolute neutrophil count (ANC) >1.5x10^9/L; platelet count >100x10^9/L; and hemoglobin (Hb) >9.0 g/dL. Note: the use of transfusion or other intervention prior to cycle 1 day 1 to achieve Hb >9.0 g/dL is acceptable.
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- Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
- The effects of Selinexor on the developing human fetus are unknown. For this reason and because Selinexor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment and for one month after treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Patients must have had surgery and/or biopsy not greater than 8 weeks prior to initial evaluation to be eligible for this study.
Who cannot join
- <!-- -->
- Patients who are receiving any other investigational agents and have had prior therapy including:
- Patients who have previously received radiation therapy (RT) to the brain.
- Patients who received chemotherapy for the treatment of their glioma
- Patients who are being treated with implanted Gliadel wafers
- Patients who are being treated with tumor treating fields.
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor or temozolomide used in study.
- 3 Patients with coagulation problems and medically significant bleeding in the month prior to start of treatment (peptic ulcers, epistaxis, spontaneous bleeding). Prior history of deep vein thrombosis (DVT) or pulmonary embolism (PE) is not exclusionary.
- 4. Patients with active uncontrolled or suspected infections
- 5. Patients with severe liver dysfunction defined as:
- Total bilirubin > 1.5 x upper limit of normal (ULN) Note: Subjects with Gilberts syndrome should not be excluded as long as total bilirubin is < 3.0 x ULN and documentation to support diagnosis is available.
- Serum glutamate pyruvate transaminase (SGPT) or called as Alanine aminotransferase (ALT) greater than or equal to 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L
- Serum glutamic oxaloacetic transaminase (SGOT) or called as Aspartate aminotransferase (AST) greater than or equal to 3 x ULN = 150 U/L; for the purpose of this study, the ULN for SGOT is 50 U/L
- Serum albumin greater than or equal to 2 x ULN
- 6. Known active hepatitis A, B, or C infection
- 7. Human immunodeficiency virus (HIV) patients are not eligible because of their immunocompromised status and overlap of side effects between highly active antiretroviral therapy (HAART) and radiation therapy.
- 8 Patients must not have significantly diseased or obstructed gastrointestinal tract malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral medication.
- 9. Pregnant women are excluded from this study because Selinexor could have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Selinexor, breastfeeding should be discontinued if the mother is treated with Selinexor. These potential risks may also apply to temozolomide used in this study.
- 10. Patients with pre-existing known or suspected radiation sensitivity syndromes will be excluded due to potential confounding effect on outcome.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Clinical Trial of 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.
Read more
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.
Read the detailed description
Background:
- Although radiation has been shown to improve outcomes in patients with glioblastoma (GBM), median survival remains poor. Even with the addition of temozolomide (TMZ) to surgical resection and radiotherapy, most GBMs will recur in field or adjacent to the high dose radiation volume.
- High rates of local failure indicate that GBM cells in situ are relatively radioresistant and that the effectiveness of GBM radiotherapy would benefit from additional radiosensitization.
- Selinexor has recently been shown to enhance the radiosensitivity of glioma cells both in vitro and in vivo.
Objectives:
-Assess the safety, tolerability, and maximum tolerated dose of selinexor when combined with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma and gliosarcoma.
Eligibility:
- Men and women greater than 18 years old
- Histologically confirmed newly diagnosed glioblastoma or gliosarcoma
- Karnofsky Performance Scale (KPS) greater than or equal to 70
- Patients who have not previously been treated with chemotherapy or radiation therapy
Design:
- This is a Phase I trial to determine the safety and tolerability of selinexor in combination with external beam radiation therapy (RT) and temozolomide in patients with newly diagnosed glioblastoma or gliosarcoma using a "3 plus 3 design" and three dose escalation levels, with 3 patients per dose level (provided no dose limiting toxicity (DLT), a maximum of 21 patients will be enrolled.
- Patients will be treated with external beam radiation therapy in a standard manner with temozolomide given daily during radiation. Selinexor will be administered concurrent with the RT/temozolomide.
- We anticipate accrual of 21 evaluable patients which will take approximately 2 years. The accrual ceiling has been set to 24 patients.
- Conditions
- Gliosarcoma, Newly Diagnosed, Glioblastoma
- Being tested
- Selinexor, Temozolomide, Generic Radiation therapy (RT), Selective serotonin receptor (5-HT3) antagonists, Olanzapine
- Keywords
- Radiotherapy, GBM, Gliosarcoma
- Medical subject headings
- Gliosarcoma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called Xpovio
Selinexor will be administered orally at an initial dose of 80 mg. The first dose will be given on day 2 of radiation and will thereafter be administered weekly on the second day of weekly radiation on weeks 1, 2, 4, and 5. If this dose level is tolerated, the dose will be escalated to 60 mg twice a week (days 1 and 4) on weeks 1,2,4,5. The third and final dose level will also be 60mg administered twice weekly for 6 weeks starting on days 1 and 4 radiation.
TemozolomideDrug
Also called Temodar
Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care.
Generic Radiation therapy (RT)Radiation
Radiation therapy (RT) will be administered daily (Monday to Friday)
Selective serotonin receptor (5-HT3) antagonistsOther
Also called Serotonin antagonists
Anti-emetic for breakthrough nausea.
OlanzapineOther
Also called Zyprexa Relprevv, Zyprexa Zydis, Zyprexa
2.5mg to 5mg once a day if weight loss is rapid.
Salt tabletsDietary supplement
Also called Sodium Chloride tablets
To treat hyponatremia, add salt tablets to participants diet per institutional guidelines.
Anti-diarrhealOther
Also called Loperamide, Imodium
Treat diarrhea with an anti-diarrheal per institutional guidelines
| Study group | Role | What they receive |
|---|---|---|
| 1/Experimental Therapy - Selinexor with Temozolomide and Radiation | Experimental | Selinexor with temozolomide and radiation Receives: Drug: Selinexor; Drug: Temozolomide; Radiation: Generic Radiation therapy (RT); Other: Selective serotonin receptor (5-HT3) antagonists; Other: Olanzapine; Dietary Supplement: Salt tablets; Other: Anti-diarrheal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Selinexor
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.
Measured: 7 weeks
Secondary outcomes (4)
Dose-limiting Toxicities of Selinexor to Concurrent Radiation Therapy and Temozolomide Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group (RTOG)
Dose-limiting toxicities of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. CTCAE: Grade 3 is severe, and Grade 4 is life-threatening. RTOG: Grade 3 Brain/Central nervous system (CNS): neurologic findings present sufficient to require home care; Skin: confluent moist desquamation other than skin folds; Eye: severe keratitis; Ear: severe external otitis; and Grade 4 Brain/CNS is serious neurologic impairment; Skin: ulceration; Eye: loss of vision; and Ear: deafness.DLT's include all adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity.
Measured: Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor.
Dose-limiting Toxicities Effects on Quality of Life (QOL)
Define the dose-limiting toxicities (DLT) effects on quality of life (QOL) in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores will be summarized. DLT's include all adverse events (AE), including clinically significant abnormal findings on laboratory evaluations, regardless of severity. Evaluations completed on participants weekly or complications requiring admission to the emergency room (ER)/hospital are also included in the collection of AEs to determine if DLT.
Measured: Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor.
Dose-limiting Toxicities (DLT) Effects on Neurocognition
Define the dose-limiting toxicities effects on neurocognition in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. DLT's include all adverse events (AE), including clinically significant abnormal findings on laboratory evaluations, regardless of severity. Evaluations completed on participants weekly or complications requiring admission to the emergency room (ER)/hospital are also included in the collection of AE's to determine if DLT.
Measured: Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor.
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
The PROMIS depression questionnaire in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 1 (never) - 5 (very often several times a day) will be summarized. A score of 1 is the best outcome. A score of 5 is worst outcome. The difference between two timepoints - baseline and close of treatment is also reported.
Measured: Baseline and completion of treatment, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start7 Jul 2020
- Primary completion29 Sep 2023
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GliosarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Kevin Camphausen, M.D., National Cancer Institute (NCI)
- Investigators
- Kevin A Camphausen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216329
- Sponsor's protocol ID
- 200027
- Other IDs
- 20-C-0027
- Status last verified
- Oct 2026
- First submitted
- 31 Dec 2019
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT04216329
- Acronym / sponsor ID
- 200027
- Conditions
- Gliosarcoma, Newly Diagnosed, Glioblastoma
- Keywords
- Radiotherapy, GBM, Gliosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Although radiation has been shown to improve outcomes in patients with glioblastoma (GBM), median survival remains poor. Even with the addition of temozolomide (TMZ) to surgical resection and radiotherapy, most GBMs will recur in field or adjacent to the high dose radiation volume.
- High rates of local failure indicate that GBM cells in situ are relatively radioresistant and that the effectiveness of GBM radiotherapy would benefit from additional radiosensitization.
- Selinexor has recently been shown to enhance the radiosensitivity of glioma cells both in vitro and in vivo.
Objectives:
-Assess the safety, tolerability, and maximum tolerated dose of selinexor when combined with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma and gliosarcoma.
Eligibility:
- Men and women greater than 18 years old
- Histologically confirmed newly diagnosed glioblastoma or gliosarcoma
- Karnofsky Performance Scale (KPS) greater than or equal to 70
- Patients who have not previously been treated with chemotherapy or radiation therapy
Design:
- This is a Phase I trial to determine the safety and tolerability of selinexor in combination with external beam radiation therapy (RT) and temozolomide in patients with newly diagnosed glioblastoma or gliosarcoma using a "3 plus 3 design" and three dose escalation levels, with 3 patients per dose level (provided no dose limiting toxicity (DLT), a maximum of 21 patients will be enrolled.
- Patients will be treated with external beam radiation therapy in a standard manner with temozolomide given daily during radiation. Selinexor will be administered concurrent with the RT/temozolomide.
- We anticipate accrual of 21 evaluable patients which will take approximately 2 years. The accrual ceiling has been set to 24 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Experimental Therapy - Selinexor with Temozolomide and Radiation | Experimental | Drug: Selinexor, Drug: Temozolomide, Radiation: Generic Radiation therapy (RT), Other: Selective serotonin receptor (5-HT3) antagonists, Other: Olanzapine, Dietary Supplement: Salt tablets, Other: Anti-diarrhealSelinexor with temozolomide and radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
Key exclusion criteria (19 listed)
- <!-- -->
- 3 Patients with coagulation problems and medically significant bleeding in the month prior to start of treatment (peptic ulcers, epistaxis, spontaneous bleeding). Prior history of deep vein thrombosis (DVT) or pulmonary embolism (PE) is not exclusionary.
- 4. Patients with active uncontrolled or suspected infections
- 6. Known active hepatitis A, B, or C infection
- 7. Human immunodeficiency virus (HIV) patients are not eligible because of their immunocompromised status and overlap of side effects between highly active antiretroviral therapy (HAART) and radiation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelinexorAlso: XpovioSelinexor will be administered orally at an initial dose of 80 mg. The first dose will be given on day 2 of radiation and will thereafter be administered weekly on the second day of weekly radiation on weeks 1, 2, 4, and 5. If this dose level is tolerated, the dose will be escalated to 60 mg twice a week (days 1 and 4) on weeks 1,2,4,5. The third and final dose level will also be 60mg administered twice weekly for 6 weeks starting on days 1 and 4 radiation. | Drug | 1/Experimental Therapy - Selinexor with Temozolomide and Radiation |
| TemozolomideAlso: TemodarTemozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. | Drug | 1/Experimental Therapy - Selinexor with Temozolomide and Radiation |
| Generic Radiation therapy (RT)Radiation therapy (RT) will be administered daily (Monday to Friday) | Radiation | 1/Experimental Therapy - Selinexor with Temozolomide and Radiation |
| Selective serotonin receptor (5-HT3) antagonistsAlso: Serotonin antagonistsAnti-emetic for breakthrough nausea. | Other | 1/Experimental Therapy - Selinexor with Temozolomide and Radiation |
| OlanzapineAlso: Zyprexa Relprevv, Zyprexa Zydis, Zyprexa2.5mg to 5mg once a day if weight loss is rapid. | Other | 1/Experimental Therapy - Selinexor with Temozolomide and Radiation |
| Salt tabletsAlso: Sodium Chloride tabletsTo treat hyponatremia, add salt tablets to participants diet per institutional guidelines. | Dietary supplement | 1/Experimental Therapy - Selinexor with Temozolomide and Radiation |
| Anti-diarrhealAlso: Loperamide, ImodiumTreat diarrhea with an anti-diarrheal per institutional guidelines | Other | 1/Experimental Therapy - Selinexor with Temozolomide and Radiation |
Primary outcome
Maximum Tolerated Dose (MTD) of Selinexor
Time frame: 7 weeks
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.
4 secondary outcomes
Dose-limiting Toxicities of Selinexor to Concurrent Radiation Therapy and Temozolomide Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group (RTOG)
Time frame: Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor.
Dose-limiting Toxicities Effects on Quality of Life (QOL)
Time frame: Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor.
Dose-limiting Toxicities (DLT) Effects on Neurocognition
Time frame: Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor.
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Time frame: Baseline and completion of treatment, up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin A Camphausen, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selinexor, Temozolomide and Generic Radiation therapy (RT) in people with Gliosarcoma and Newly Diagnosed, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Selinexor (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.