Clinical Trial Details
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NCT01986348 : A Phase 2 Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Patients With Recurrent Gliomas
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Pathologically confirmed GBM (including all histologic variants) at first diagnosis
with radiographic evidence of recurrent disease after treatment with radiotherapy and

- 18 years of age or older

- Patients enrolling in the medical arm (Arms 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

- Patients 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.

- Patients must not have significantly diseased or obstructed gastrointestinal tract,
malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral

- 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.
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