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

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

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

Sponsors & Collaborators

• Karyopharm Therapeutics Inc

  lead INDUSTRY

Principal Investigators

• Andrew B Lassman, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-08

Primary Completion

2023-07-03

Completion

2023-07-03

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations