Overview

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

Status:
Terminated
Trial end date:
2020-01-23
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral selinexor in participants with recurrent gliomas.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Karyopharm Therapeutics Inc
Karyopharm Therapeutics, Inc
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.