Last updated: January 24, 2023
Sponsor: Karyopharm Therapeutics Inc
Overall Status: Terminated
Phase
2
Condition
Brain Cancer
Cancer/tumors
Gliomas
Treatment
N/AClinical Study ID
NCT01986348
KCP-330-004
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Pathologically confirmed GBM (including all histologic variants) at first diagnosiswith radiographic evidence of recurrent disease after treatment with radiotherapy andtemozolomide;
- 18 years of age or older
- Participants enrolling in the medical arm (Arms B, C and D) must be on a stable ordecreasing dose of corticosteroids (or none) for at least 5 days prior to the baselineMRI;
- Measurable disease (according to RANO guidelines)
- Surgical arm (Arm A) must be predicted pre-operatively to have sufficiently sizedtumor to be resected and provide tissue samples for exploratory assessments.
Exclusion
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 monthprior 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 gastrointestinaltract, malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oralmedications.
- Prior treatment with bevacizumab or other direct VEGF/ VEGFR inhibitors. For anyquestion 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 otherchemotherapy or investigational agents prior to start of treatment within study.
Study Design
Total Participants: 76
Study Start date:
March 03, 2014
Estimated Completion Date:
January 23, 2020
Study Description
Connect with a study center
The Phase I Unit, Dept. of Oncology, Rigshospitalet
Copenhagen, DK-2100
DenmarkSite Not Available
University of Groningen Faculty of Medical Sciences, Medical Oncology
Groningen, 9713 GZ
NetherlandsSite Not Available
Erasmus MC-Daniel den Hoed Cancer Center- Neuro-Oncology Unit
Rotterdam, 3008AE
NetherlandsSite Not Available
Dana Farber Cancer Institute, Center for Neuro-Oncology
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Columbia University, Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesSite Not Available

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