A Phase 1 interventional study of Selinexor and Temozolomide in Gliosarcoma, Newly Diagnosed and Glioblastoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
Background:
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:
Design:
488 studies on the registry are indexed under Gliosarcoma; 14 are open to participants now.
This study's enrollment of 11 is below the median of 37 across 389 interventional studies indexed under Gliosarcoma.
Browse Gliosarcoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Histological diagnosis
EXCLUSION CRITERIA:
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Patients who are receiving any other agents and have had prior therapy including:
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:
Serum albumin greater than or equal to 2 x ULN
6. Known active hepatitis A, B, or C infection
7. (HIV) patients are not eligible because of their 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Selinexor with temozolomide and radiation
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
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.
Also known as: Xpovio
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.
Also known as: Temodar
Radiation therapy (RT) will be administered daily (Monday to Friday)
Anti-emetic for breakthrough nausea.
Also known as: Serotonin antagonists
2.5mg to 5mg once a day if weight loss is rapid.
Also known as: Zyprexa Relprevv, Zyprexa Zydis, Zyprexa
To treat hyponatremia, add salt tablets to participants diet per institutional guidelines.
Also known as: Sodium Chloride tablets
Treat diarrhea with an anti-diarrheal per institutional guidelines
Also known as: Loperamide, Imodium
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.
Time frame: 7 weeks
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.
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)
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.
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
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.
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
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.
Time frame: Baseline and completion of treatment, up to 3 years
Dose-limiting Toxicities (DLT) Effects on Quality of Life (QOL) Using the MD Anderson Symptom Inventory for Brain Tumors (MDSAI-BT)
DLT effects on quality of life (QOL) using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) 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 0 (symptoms not present)-10 (as bad as you can imagine) will be summarized. A score of 0 is the best outcome. A score of 10 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported.
Time frame: Baseline and close of treatment, up to 3 years
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
The PROMIS anxiety scale 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 (always) will be summarized. A score of 1 is the best outcome. A score of 5 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported.
Time frame: Baseline and completion of treatment, up to 3 years
National Cancer Institute (NCI) Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The NCI PRO-CTCAE 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 0 (None) - 4 (Very severe) will be summarized. A score of 0 is the best outcome. A score of 4 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported.
Time frame: Baseline and completion of treatment, up to 3 years
Neuro-quality of Life (QOL) Assessment Cognition Function
The Neuro-QOL assessment Cognition Function 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 5 (Never) -1 (Very often-several times a day), e.g., thinking slow, will be summarized. A score of 5 is the best outcome. A score of 1 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported.
Time frame: Baseline and completion of treatment, up to 3 years
Number of Participants With Serious and/or Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event.
Time frame: Adverse events are documented from the first study intervention, Study Day 1, through 30 days after the subject received the last study drug administration, an average of 2.5 months.
| Milestone | Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|---|
| Started | 0 | 3 | 6 | 2 |
| Completed | 0 | 3 | 6 | 2 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| mg/m^2 | All Participants |
|---|---|
| Maximum Tolerated Dose (MTD) of Selinexor | 60 |
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.
| toxicities | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Grade 3 DLT - CTCAE | 8 | 19 | 6 |
| Grade 3 DLT - RTOG | 0 | 0 | 0 |
| Grade 4 DLT - CTCAE | 1 | 0 | 2 |
| Grade 4 DLT - RTOG | 0 | 0 | 0 |
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.
| toxicities | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Grade 3 DLT-CTCAE | 0 | 0 | 0 |
| Grade 3 DLT-RTOG | 0 | 0 | 0 |
| Grade 4 DLT-CTCAE | 0 | 0 | 0 |
| Grade 4 DLT-RTOG | 0 | 0 | 0 |
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.
| toxicities | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Grade 3 DLT-CTCAE | 0 | 0 | 0 |
| Grade 3 DLT-RTOG | 0 | 00 | 0 |
| Grade 4 DLT-CTCAE | 0 | 0 | 0 |
| Grade 4 DLT-RTOG | 0 | 0 | 0 |
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.
| Score on a scale | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Baseline | 1.63 (1 to 3) | 1.71 (1.125 to 2.625) | 1.71 (1.125 to 2.625) |
| Completion of treatment | 1.22 (1 to 1.75) | 2.42 (1 to 3.25) | 2.42 (1 to 3.25) |
| Difference between two timepoints | -0.41 (-0.625 to 0.25) | 0.71 (-0.125 to 1.625) | 0.71 (-0.125 to 1.625) |
DLT effects on quality of life (QOL) using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) 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 0 (symptoms not present)-10 (as bad as you can imagine) will be summarized. A score of 0 is the best outcome. A score of 10 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported.
| Scores on a scale | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Baseline (BL) | 1.21 (0 to 5) | 1.17 (0.678 to 1.857) | 1.17 (0.678 to 1.857) |
| Completion of treatment (COT) | 1.6 (0.179 to 3.214) | 1.77 (0.687 to 2.6) | 1.77 (0.687 to 2.6) |
| Difference between two timepoints (BL & COT) | 0.39 (0.179 to 1.5) | 0.61 (.006 to 1.072) | 0.61 (.009 to 1.072) |
The PROMIS anxiety scale 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 (always) will be summarized. A score of 1 is the best outcome. A score of 5 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported.
| Score on a scale | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Baseline (BL) | 1.63 (1 to 3) | 1.71 (1.125 to 2.625) | 1.71 (1.125 to 2.625) |
| Completion of treatment (COT) | 1.22 (1 to 1.75) | 2.42 (1 to 3.25) | 2.42 (1 to 3.25) |
| Difference between two timepoints (BL & COT) | -0.41 (-0.625 to 0.25) | 0.71 (-0.125 to 1.625) | 0.71 (-0.125 to 1.625) |
The NCI PRO-CTCAE 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 0 (None) - 4 (Very severe) will be summarized. A score of 0 is the best outcome. A score of 4 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported.
| Scores on a scale | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Baseline (BL) | 0.29 (0 to 0.85) | 0.53 (0.25 to 0.95) | 0.53 (0.25 to 0.95) |
| Completion of treatment (COT) | 0.87 (0.3 to 1.25) | 0.83 (0.684 to 1.05) | 0.83 (0.684 to 1.05) |
| Difference between two timepoints (BL & COT) | 0.58 (-0.05 to 1.145) | 0.3 (0.1 to 0.434) | 0.3 (0.1 to 0.434) |
The Neuro-QOL assessment Cognition Function 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 5 (Never) -1 (Very often-several times a day), e.g., thinking slow, will be summarized. A score of 5 is the best outcome. A score of 1 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported.
| Score on a scale | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Baseline (BL) | 4.42 (3.125 to 5) | 4.17 (3.625 to 4.5) | 4.17 (3.625 to 4.5) |
| Completion of treatment (COT) | 4.39 (2.25 to 5) | 3.67 (3.125 to 4.265) | 3.67 (3.125 to 4.265) |
| Difference between two timepoints (BL & COT) | -0.03 (-0.875 to 0.625) | -0.875 (-0.11 to -0.875) | -0.875 (-0.11 to -0.875) |
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event.
| Participants | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Number of Participants With Serious and/or Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 3 | 6 | 2 |
Collected over Adverse events are documented from the first study intervention, Study Day 1, through 30 days after the subject received the last study drug administration, an average of 2.5 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | 1/3 (33.3%) | 2/3 (66.7%) | 3/3 (100%) |
| Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | 6/6 (100%) | 2/6 (33.3%) | 6/6 (100%) |
| Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | 2/2 (100%) | 0/2 (0%) | 2/2 (100%) |
| Event | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| Infections and infestations - Other, specify: COVID-19Infections and infestations | 1/3 | 0/6 | 0/2 |
| FallInjury, poisoning and procedural complications | 1/3 | 1/6 | 0/2 |
| Muscle weakness lower limbMusculoskeletal and connective tissue disorders | 1/3 | 0/6 | 0/2 |
| Muscle weakness upper limbMusculoskeletal and connective tissue disorders | 1/3 | 0/6 | 0/2 |
| EncephalopathyNervous system disorders | 1/3 | 1/6 | 0/2 |
| Generalized muscle weaknessMusculoskeletal and connective tissue disorders | 0/3 | 1/6 | 0/2 |
| SeizureNervous system disorders | 0/3 | 1/6 | 0/2 |
| AnxietyPsychiatric disorders | 0/3 | 1/6 | 0/2 |
| Event | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation |
|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 0/3 | 3/6 | 2/2 |
| FatigueGeneral disorders and administration site conditions | 3/3 | 3/6 | 1/2 |
| Dermatitis radiationInjury, poisoning and procedural complications | 0/3 | 2/6 | 2/2 |
| Blood lactate dehydrogenase increasedInvestigations | 3/3 | 5/6 | 1/2 |
| Lymphocyte count decreasedInvestigations | 3/3 | 6/6 | 2/2 |
| Neutrophil count decreasedInvestigations | 0/3 | 1/6 | 2/2 |
| Platelet count decreasedInvestigations | 1/3 | 4/6 | 2/2 |
| White blood cell decreasedInvestigations | 1/3 | 3/6 | 2/2 |
| AnorexiaMetabolism and nutrition disorders | 0/3 | 2/6 | 2/2 |
| HyperglycemiaMetabolism and nutrition disorders | 3/3 | 5/6 | 2/2 |
No participants were enrolled in Dose Level -1.
| Age, Categorical(Participants) | Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Total |
|---|---|---|---|---|---|
| <=18 years | — | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | — | 3 | 5 | 2 | 10 |
| >=65 years | — | 0 | 1 | 0 | 1 |
| Age, Continuous(years) | Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Total |
|---|---|---|---|---|---|
| Mean | — | 54.33 ± 9.29 | 61 ± 5.66 | 57 ± 5.66 | 58.45 ± 6.77 |
| Sex: Female, Male(Participants) | Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Total |
|---|---|---|---|---|---|
| Female | — | 3 | 3 | 1 | 7 |
| Male | — | 0 | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | — | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | — | 3 | 6 | 2 | 11 |
| Unknown or Not Reported | — | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | — | 0 | 0 | 0 | 0 |
| Asian | — | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | — | 0 | 0 | 0 | 0 |
| Black or African American | — | 0 | 0 | 0 | 0 |
| White | — | 3 | 6 | 2 | 11 |
| More than one race | — | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | — | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Total |
|---|---|---|---|---|---|
| United States | — | 3 | 6 | 2 | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data available during the study and indefinitely.
Access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Selinexor · Temozolomide
National Cancer Institute (NCI) →