Phase 2 Study of Selinexor (KPT-330) in Patients With Recurrent Glioblastoma or Other Brain Cancers After Failure of Radiation and Temozolomide

Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Recurrent Glioblastoma
NCT ID: NCT01986348 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-029

 

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

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Patrick Wen, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Scott Plotkin, MD, PhD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Lisa Doherty, ldoherty1@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Pathologically confirmed GBM (including all histologic variants) with radiographic evidence of recurrent disease after treatment with temozolomide and radiotherapy - 18 years of age or older - Measurable disease - Surgical arm (Arm A) must be predicted pre-operatively to have sufficient size of tumor for 500 mg of enhancing tumor and 300 mg of non-enhancing tumor to be resected Exclusion Criteria: - Markedly decreased visual acuity if attributed to other causes than GBM - Known active hepatitis A, B, or C - Not have significant diseased or obstructed GI malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral medications - Prior treatment with bevacizumab or other direct VEGF/ VEGFR inhibitors - Dehydration of NCI-CTCAE grade ≥ 1
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