NCT04421378

A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

A Phase 1/2 Study of Selinexor in Combination With Standard of Care (SoC) Therapy for Newly Diagnosed or Recurrent Glioblastoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion) and a Phase 2 randomized efficacy exploration study and will independently evaluate 3 different combination regimens in 3 treatment arms in patients with nGBM (Arms A and B) or with rGBM (Arm C). * Arm A: evaluating the combination of selinexor with radiation therapy (S-RT) in nGBM participants with uMGMT * Arm B: evaluating the combination of selinexor with radiation therapy and temozolomide (TMZ) (S-TRT) in nGBM participants with methylated-O6-methylguanine-DNA-methyltransferase (mMGMT) * Arm C: evaluating the combination of selinexor with lomustine (or carmustine, if lomustine is not available) (S-L/C) in rGBM participants regardless of MGMT status * Arm D: evaluating the combination of selinexor with bevacizumab in rGBM participants regardless of MGMT status * Arm E: evaluating the combination of selinexor with tumor treating fields (TTField) in rGBM participants regardless of MGMT status

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Selinexor	Dose and Formulation: 20 milligram (mg); Tablet Route of Administration: Oral
DRUG	Temozolomide (TMZ)	Dose strength and Formulation: 5, 20, 100, 140, 180, or 250 mg; Capsule Route of Administration: Oral
DRUG	Lomustine (CCNU)	Dose and Formulation: 10, 40, or 100 mg; Capsule Route of Administration: Oral
RADIATION	Standard Fractionated Radiation therapy (RT)	Radiation Therapy Oncology Group (RTOG) or European Organisation for Research and Treatment of Cancer (EORTC) methodologies of approximately 60 Gy in 30 fractions.
DRUG	Bevacizumab	Dose and Formulation: 10 mg/kg; Route of Administration: Intravenous
DEVICE	TTField	Dose and Formulation: 200 kHz ≥18h/day; Route of administration: Scalp application of transducer arrays.
DRUG	Carmustine	Dose and Formulation: 150 or 200 mg/m\^2; Route of Administration: Intravenous

Timeline

• Start date: 2020-06-08
• Primary completion: 2023-07-03
• Completion: 2023-07-03
• First posted: 2020-06-09
• Last updated: 2024-12-16
• Results posted: 2024-12-16

Locations

18 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study