Trial Outcomes & Findings for Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma (NCT NCT04216329)

Last Updated: 2026-01-23

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

7 weeks

Results posted on

2026-01-23

Participant Flow

No participants were enrolled in Dose Level -1.

Participant milestones

Participant milestones
Measure	Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 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.	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Overall Study STARTED	3	6	2
Overall Study COMPLETED	3	6	2
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level -1: Selinexor 80mg on Weeks 1, 4 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.	Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=3 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 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.	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	—	3 Participants n=4 Participants	5 Participants n=9 Participants	2 Participants n=220 Participants	10 Participants n=3 Participants
Age, Categorical >=65 years	—	0 Participants n=4 Participants	1 Participants n=9 Participants	0 Participants n=220 Participants	1 Participants n=3 Participants
Age, Continuous	—	54.33 years STANDARD_DEVIATION 9.29 • n=4 Participants	61 years STANDARD_DEVIATION 5.66 • n=9 Participants	57 years STANDARD_DEVIATION 5.66 • n=220 Participants	58.45 years STANDARD_DEVIATION 6.77 • n=3 Participants
Sex: Female, Male Female	—	3 Participants n=4 Participants	3 Participants n=9 Participants	1 Participants n=220 Participants	7 Participants n=3 Participants
Sex: Female, Male Male	—	0 Participants n=4 Participants	3 Participants n=9 Participants	1 Participants n=220 Participants	4 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	3 Participants n=4 Participants	6 Participants n=9 Participants	2 Participants n=220 Participants	11 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	—	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Race (NIH/OMB) White	—	3 Participants n=4 Participants	6 Participants n=9 Participants	2 Participants n=220 Participants	11 Participants n=3 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants
Region of Enrollment United States	—	3 participants n=4 Participants	6 participants n=9 Participants	2 participants n=220 Participants	11 participants n=3 Participants

PRIMARY outcome

Timeframe: 7 weeks

Outcome measures

Outcome measures
Measure	All Participants n=11 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Maximum Tolerated Dose (MTD) of Selinexor	60 mg/m^2	—	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
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) Grade 3 DLT - CTCAE	8 toxicities	19 toxicities	6 toxicities
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) Grade 3 DLT - RTOG	0 toxicities	0 toxicities	0 toxicities
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) Grade 4 DLT - CTCAE	1 toxicities	0 toxicities	2 toxicities
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) Grade 4 DLT - RTOG	0 toxicities	0 toxicities	0 toxicities

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Dose-limiting Toxicities Effects on Quality of Life (QOL) Grade 3 DLT-CTCAE	0 toxicities	0 toxicities	0 toxicities
Dose-limiting Toxicities Effects on Quality of Life (QOL) Grade 3 DLT-RTOG	0 toxicities	0 toxicities	0 toxicities
Dose-limiting Toxicities Effects on Quality of Life (QOL) Grade 4 DLT-CTCAE	0 toxicities	0 toxicities	0 toxicities
Dose-limiting Toxicities Effects on Quality of Life (QOL) Grade 4 DLT-RTOG	0 toxicities	0 toxicities	0 toxicities

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Dose-limiting Toxicities (DLT) Effects on Neurocognition Grade 3 DLT-CTCAE	0 toxicities	0 toxicities	0 toxicities
Dose-limiting Toxicities (DLT) Effects on Neurocognition Grade 3 DLT-RTOG	0 toxicities	00 toxicities	0 toxicities
Dose-limiting Toxicities (DLT) Effects on Neurocognition Grade 4 DLT-CTCAE	0 toxicities	0 toxicities	0 toxicities
Dose-limiting Toxicities (DLT) Effects on Neurocognition Grade 4 DLT-RTOG	0 toxicities	0 toxicities	0 toxicities

SECONDARY outcome

Timeframe: Baseline and completion of treatment, up to 3 years

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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale Baseline	1.63 Score on a scale Interval 1.0 to 3.0	1.71 Score on a scale Interval 1.125 to 2.625	1.71 Score on a scale Interval 1.125 to 2.625
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale Completion of treatment	1.22 Score on a scale Interval 1.0 to 1.75	2.42 Score on a scale Interval 1.0 to 3.25	2.42 Score on a scale Interval 1.0 to 3.25
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale Difference between two timepoints	-0.41 Score on a scale Interval -0.625 to 0.25	0.71 Score on a scale Interval -0.125 to 1.625	0.71 Score on a scale Interval -0.125 to 1.625

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and close of treatment, up to 3 years

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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Dose-limiting Toxicities (DLT) Effects on Quality of Life (QOL) Using the MD Anderson Symptom Inventory for Brain Tumors (MDSAI-BT) Baseline (BL)	1.21 Scores on a scale Interval 0.0 to 5.0	1.17 Scores on a scale Interval 0.678 to 1.857	1.17 Scores on a scale Interval 0.678 to 1.857
Dose-limiting Toxicities (DLT) Effects on Quality of Life (QOL) Using the MD Anderson Symptom Inventory for Brain Tumors (MDSAI-BT) Completion of treatment (COT)	1.6 Scores on a scale Interval 0.179 to 3.214	1.77 Scores on a scale Interval 0.687 to 2.6	1.77 Scores on a scale Interval 0.687 to 2.6
Dose-limiting Toxicities (DLT) Effects on Quality of Life (QOL) Using the MD Anderson Symptom Inventory for Brain Tumors (MDSAI-BT) Difference between two timepoints (BL & COT)	0.39 Scores on a scale Interval 0.179 to 1.5	0.61 Scores on a scale Interval 0.006 to 1.072	0.61 Scores on a scale Interval 0.009 to 1.072

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and completion of treatment, up to 3 years

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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale Difference between two timepoints (BL & COT)	-0.41 Score on a scale Interval -0.625 to 0.25	0.71 Score on a scale Interval -0.125 to 1.625	0.71 Score on a scale Interval -0.125 to 1.625
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale Baseline (BL)	1.63 Score on a scale Interval 1.0 to 3.0	1.71 Score on a scale Interval 1.125 to 2.625	1.71 Score on a scale Interval 1.125 to 2.625
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale Completion of treatment (COT)	1.22 Score on a scale Interval 1.0 to 1.75	2.42 Score on a scale Interval 1.0 to 3.25	2.42 Score on a scale Interval 1.0 to 3.25

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and completion of treatment, up to 3 years

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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
National Cancer Institute (NCI) Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Baseline (BL)	0.29 Scores on a scale Interval 0.0 to 0.85	0.53 Scores on a scale Interval 0.25 to 0.95	0.53 Scores on a scale Interval 0.25 to 0.95
National Cancer Institute (NCI) Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Completion of treatment (COT)	0.87 Scores on a scale Interval 0.3 to 1.25	0.83 Scores on a scale Interval 0.684 to 1.05	0.83 Scores on a scale Interval 0.684 to 1.05
National Cancer Institute (NCI) Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Difference between two timepoints (BL & COT)	0.58 Scores on a scale Interval -0.05 to 1.145	0.3 Scores on a scale Interval 0.1 to 0.434	0.3 Scores on a scale Interval 0.1 to 0.434

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and completion of treatment, up to 3 years

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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Neuro-quality of Life (QOL) Assessment Cognition Function Baseline (BL)	4.42 Score on a scale Interval 3.125 to 5.0	4.17 Score on a scale Interval 3.625 to 4.5	4.17 Score on a scale Interval 3.625 to 4.5
Neuro-quality of Life (QOL) Assessment Cognition Function Completion of treatment (COT)	4.39 Score on a scale Interval 2.25 to 5.0	3.67 Score on a scale Interval 3.125 to 4.265	3.67 Score on a scale Interval 3.125 to 4.265
Neuro-quality of Life (QOL) Assessment Cognition Function Difference between two timepoints (BL & COT)	-0.03 Score on a scale Interval -0.875 to 0.625	-0.875 Score on a scale Interval -0.11 to -0.875	-0.875 Score on a scale Interval -0.11 to -0.875

OTHER_PRE_SPECIFIED outcome

Timeframe: From initiation of treatment on protocol to progression as per RANO criteria or death due to disease progression, approximately months

PFS is defined as the time from initiation of treatment on protocol to progression as per Response Assessment in Neuro-Oncology (RANO) criteria or death due to disease progression. Progressive disease is at least two sequential scans separated by at ≥4 weeks both exhibiting ≥25% increase in sum of products of perpendicular diameters or ≥40% increase in total volume of enhancing lesions. Clear clinical deterioration not attributable to other causes apart from tumor or attributable to changes in steroid use. Failure to return for evaluation as a result of death or deteriorating condition.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From initiation of treatment on protocol to date of death due to any cause, approximately months.

OS is defined as the time from initiation of treatment on protocol to date of death due to any cause. For participants alive as of last follow-up, time to death will be censored at last contact date.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received Selinexor with temozolomide and radiation. Selinexor: 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. Temozolomide: 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 therapy (RT) will be administered daily (Monday to Friday) Selective serotonin receptor (5-HT3) antagonists: Anti-emetic for breakthrough nausea. Olanzapine: 2.5mg to 5mg once a day if weight loss is rapid. Salt tablets: To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. Anti-diarrheal: Treat diarrhea with an anti-diarrheal per institutional guidelines	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 Participants Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Number of Participants With Serious and/or Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	3 Participants	6 Participants	2 Participants

Adverse Events

Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation

Serious events: 2 serious events

Other events: 6 other events

Deaths: 5 deaths

Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=3 participants at risk Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 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.	Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation n=6 participants at risk Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 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.	Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation n=2 participants at risk Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 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.
Psychiatric disorders Anxiety	0.00% 0/3 • 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.	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/2 • 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.
Nervous system disorders Encephalopathy	33.3% 1/3 • Number of events 1 • 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.	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/2 • 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.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Number of events 1 • 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.	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/2 • 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.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • 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.	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/2 • 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.
Infections and infestations Infections and infestations - Other, COVID-19	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/6 • 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.	0.00% 0/2 • 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.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/6 • 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.	0.00% 0/2 • 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.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/6 • 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.	0.00% 0/2 • 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.
Nervous system disorders Seizure	0.00% 0/3 • 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.	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/2 • 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.

Other adverse events

Additional Information

Dr. Kevin A. Camphausen

National Cancer Institute

Phone: 240-760-6205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place