Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
NCT03973918 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2024-10-31
Summary
The goal of this study is to estimate the efficacy of encorafenib and binimetinib as measured by radiographic response in recurrent high-grade primary brain tumors.
Conditions
- High Grade Glioma
- BRAF V600E
- BRAF V600K
- Anaplastic Astrocytoma
- Anaplastic Pleomorphic Xanthoastrocytoma
- Gliosarcoma
- Glioblastoma
Interventions
- DRUG
-
450mg QD 28 day cycle
- DRUG
-
Binimetinib
45mg BID 28 day cycle
- BIOLOGICAL
-
Research Bloods
Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
- BIOLOGICAL
-
Tumor Tissue
at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - collaborator INDUSTRY
-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
lead OTHER
Principal Investigators
-
Karisa C Schreck, MD · ABTC
-
Stuart A Grossman, MD · ABTC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-29
- Primary Completion
- 2022-04-30
- Completion
- 2023-10-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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