Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas

Stopped early · Phase 2

Conditions studied: Glioblastoma, Glioma

In brief

This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral selinexor in participants with recurrent gliomas.

Key facts

Study ID

NCT01986348

Run by

Karyopharm Therapeutics Inc

People needed

76

Starts

2014-03-03

Expected to finish

2020-01-23

Last updated by the study team

2023-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically confirmed GBM (including all histologic variants) at first diagnosis with radiographic evidence of recurrent disease after treatment with radiotherapy and temozolomide;
• 18 years of age or older
• Participants enrolling in the medical arm (Arms B, C and D) must be on a stable or decreasing dose of corticosteroids (or none) for at least 5 days prior to the baseline MRI;
• Measurable disease (according to RANO guidelines)
• Surgical arm (Arm A) must be predicted pre-operatively to have sufficiently sized tumor to be resected and provide tissue samples for exploratory assessments.

You may not qualify if…

• Markedly decreased visual acuity if attributed to other causes than GBM.
• Known active hepatitis A, B, or C
• Participants with coagulation problems and medically significant bleeding in the month prior to start of treatment (e.g., peptic ulcer, epistaxis, spontaneous bleeding). Prior history of DVT or PE is not exclusionary.
• Participants must not have significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral medications.
• Prior treatment with bevacizumab or other direct VEGF/ VEGFR inhibitors. For any question of the definition of a direct VEGF/VEGFR inhibitor, consult Sponsor.
• Arms C and D only: body surface area < 1.2 m².
• < 24 days from prior temozolomide, < 6 weeks from nitrosourea, < 4 weeks from other chemotherapy or investigational agents prior to start of treatment within study.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute, Center for Neuro-Oncology — Boston, Massachusetts, United States
• Columbia University, Herbert Irving Comprehensive Cancer Center — New York, New York, United States
• The Phase I Unit, Dept. of Oncology, Rigshospitalet — Copenhagen, Denmark
• University of Groningen Faculty of Medical Sciences, Medical Oncology — Groningen, Netherlands
• Erasmus MC-Daniel den Hoed Cancer Center- Neuro-Oncology Unit — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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