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Alkylating agents

Selinexor for Glioblastoma

Phase 1 & 2
Waitlist Available
Led By Andrew B Lassman, MD
Research Sponsored by Karyopharm Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years at the time of informed consent and ≥22 year for Arm E.
Renal function: calculated (Cockcroft-Gault) or measured creatinine clearance ≥30 milliliter per minute (mL/min)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 months
Awards & highlights

Study Summary

This trial will study the effects of selinexor in combination with standard of care therapy for newly diagnosed or recurrent glioblastoma. The study will be conducted in 2 phases and will evaluate 3 different combination regimens in 3 treatment arms.

Eligible Conditions
  • Glioblastoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1a: Maximum Tolerated Dose Per Arm: Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Phase 1a: Number of Participants with Adverse Events (AEs) with Grade Greater Than or Equal to (>=) 3, Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation
Phase 1a: Recommended Phase 2 Dose Per Arm
+4 more
Secondary outcome measures
Phase 1a/1b: Apparent Clearance (CL) of Selinexor
Phase 1a/1b: Area Under the Concentration-time Curve (AUC) of Selinexor
Phase 1a/1b: Disease Control Rate (DCR) Based on Modified Response Assessment in Neuro-Oncology Criteria in Arm C, D and E
+23 more

Side effects data

From 2017 Phase 2 trial • 116 Patients • NCT02025985
88%
Nausea
72%
Vomiting
52%
Anaemia
48%
Thrombocytopenia
48%
Fatigue
48%
Decreased Appetite
48%
Weight Decreased
28%
Dizziness
28%
Insomnia
28%
Abdominal Pain
28%
Asthenia
28%
Dysgeusia
28%
Vision Blurred
28%
Constipation
24%
Dyspnoea
24%
Hypokalaemia
24%
Diarrhoea
16%
Hyponatraemia
16%
Urinary Tract Infection
12%
Cough
12%
Pulmonary Embolism
12%
Pyrexia
12%
Oedema Peripheral
12%
Hypomagnesaemia
12%
Anxiety
12%
Stomatitis
12%
Headache
12%
Abdominal Distension
12%
Malaise
8%
Device Occlusion
8%
Cystitis
8%
Laryngitis
8%
Back Pain
8%
Hydronephrosis
8%
Ascites
8%
Ileus
8%
Dehydration
8%
Hyperglycaemia
8%
Pleural Effusion
8%
Face Oedema
8%
Somnolence
8%
Visual Impairment
8%
Muscular Weakness
8%
Agitation
8%
Hypotension
8%
Oedema
8%
Neutropenia
8%
Lung Infection
4%
Dysuria
4%
Haematuria
4%
Confusional State
4%
Alopecia
4%
Vertigo
4%
Hypertension
4%
Vaginal Haemorrhage
4%
Pneumothorax
4%
Embolism
4%
Dry Mouth
4%
Peripheral Sensory Neuropathy
4%
Pneumonia
4%
Arthralgia
4%
Muscle Spasms
4%
Depression
4%
Hallucination
4%
Contusion
4%
Device Related Infection
4%
Acute Kidney Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Phase 1: Arm B: Selinexor+Temozolomide+Radiation TherapyExperimental Treatment3 Interventions
Participants with nGBM mMGMT will receive 40-80 mg of selinexor oral tablet QW across dose level -1, 1, 2, 2a, 2b and 3a and 75 mg/m^2 of temozolomide oral capsule QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg (dose level 2a) or 80 mg (dose level 2b and 3a) of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m^2 (started from Cycle 3) and increase to 200 mg/m^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycle 4 to 8 during adjuvant therapy period. Participants will continue selinexor weekly per dose level assigned until PD.
Group II: Phase 1: Arm A: Selinexor+Radiation TherapyExperimental Treatment2 Interventions
Participants with nGBM uMGMT will receive 60 to 80 milligram (mg) of selinexor oral tablet once weekly (QW) across dose level -1, 1, 2, and 3 in combination with 2 Gray (Gy) radiation therapy (RT) daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2 and subsequently will continue at 80 mg QW until progressive disease (PD) during adjuvant therapy period.
Group III: Arm E: Selinexor+TTFieldExperimental Treatment2 Interventions
Participants with rGBM will receive 60-80 mg of selinexor oral tablet QW across dose level -1, 1 and will receive scalp application of 200 kilohertz (kHz) of transducer array ≥18 hours/day daily for each cycle in 28 day cycle for all cycles.
Group IV: Arm D: Selinexor+BevacizumabExperimental Treatment2 Interventions
Participants with rGBM will receive 60-80 mg of selinexor oral tablet QW across dose level -1, 1 and 10 mg/kg of Bevacizumab intravenous (IV) infusion every 2 weeks (Q2W) in 28-day cycle for all cycles.
Group V: Arm C: Selinexor+Lomustine/CarmustineExperimental Treatment3 Interventions
Participants with rGBM uMGMT or mMGMT will receive 40-80 mg of selinexor oral tablet QW across dose level -1, 1, 2, 2a, and 3 and 90-110 mg/m^2 of lomustine or 150-200 mg/m^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each cycle across dose level -1, 1, 2, 2a, and 3 in a 42-day cycle for all cycles.
Group VI: Arm C Control: Lomustine/CarmustineActive Control2 Interventions
Participants with rGBM uMGMT or mMGMT will receive 110 mg/m^2 of lomustine or 200 mg/m^2 of Carmustine (substituted if lomustine is not available) capsule on Day 1 of each cycle in a 42-day cycle for all cycles.
Group VII: Arm A Control: Temozolomide+Radiation TherapyActive Control2 Interventions
Participants with nGBM uMGMT will receive 75 milligram per meter square (mg/m^2) of temozolomide oral capsule once daily (QD) in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 150 mg/m^2 (started from Cycle 3) and increase to 200 mg/m^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycles 4 to 8 cycles during adjuvant therapy period.
Group VIII: Arm B Control: Temozolomide+Radiation TherapyActive Control2 Interventions
Participants with nGBM mMGMT will receive 75 mg/m^2 of temozolomide oral capsule QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 150 mg/m^2 (started from Cycle 3) and increase to 200 mg/m^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycles 4 to 8 during adjuvant therapy period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carmustine
1990
Completed Phase 3
~1790
Bevacizumab
2013
Completed Phase 4
~5280
Selinexor
2020
Completed Phase 2
~1360
Temozolomide (TMZ)
2005
Completed Phase 3
~760

Find a Location

Who is running the clinical trial?

Karyopharm Therapeutics IncLead Sponsor
87 Previous Clinical Trials
7,762 Total Patients Enrolled
1 Trials studying Glioblastoma
76 Patients Enrolled for Glioblastoma
Andrew B Lassman, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
76 Total Patients Enrolled
1 Trials studying Glioblastoma
76 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies does Selinexor typically alleviate?

"Selinexor is routinely used for disease progression, yet it can also be helpful in the management of malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer and other end-of-life directives."

Answered by AI

Could you please provide a synopsis of prior experiments related to Selinexor?

"Selinexor was first trialled at City of Hope Medical Center in the year 2000, and 1381 trials have been finished. Currently 632 studies are on-going; a large proportion being conducted within New york and Massachusetts."

Answered by AI

How many health centers in this city are administering the research?

"To make it easier for participants, this medical trial is enrolling patients at a grand total of 18 sites. The facilities are located in cities such as New york, Boston and Seattle alongside other locales. Should you choose to join the study, selecting the closest option can help reduce your travel requirements."

Answered by AI

What is the upper limit of individuals partaking in this trial?

"The sponsor, Karyopharm Therapeutics Inc., requires 474 eligible participants to carry out this trial. There are multiple sites located in New york, Massachusetts, Boston and Washington where the study is being conducted - such as Columbia University Irving Medical Center and Dana Farber Cancer Institute."

Answered by AI

Is enrollment currently open for this research experiment?

"Confirmed, the clinical trial is still open for enrollment. It was first listed on the 8th of June 2020 and underwent its last revision on April 1st 2021."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of Washington - Alvord Brain Tumor Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

My Father just had tumor removed 4 cm gmb.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. University of Washington - Alvord Brain Tumor Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
~16 spots leftby Mar 2025