Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG (NCT03973918) | Clinical Trial Compass
TerminatedPhase 2
Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
Stopped: NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer
United States5 participantsStarted 2019-07-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients receiving any other standard or investigational agents are ineligible.
✓. Patients with history or current evidence of the following conditions are excluded: neuromuscular disorder with associated elevated CK (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy), pancreatitis, retinal vein occlusion, uncontrolled HIV, or Hepatitis B/C. An exception will be made for (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and for subjects with cleared HBV and HCV infections, who may enroll in the study.
✓. Patients must have measurable (defined by at least 1 cm x 1 cm) contrast-enhancing disease by MRI imaging within 30 days of starting treatment.
✓. The following intervals from previous treatments are required to be eligible:
✓. Patients must be 18 years of age or older.
✓. Patients must have a Karnofsky Performance (KPS) Status ≥ 60%
✓. Patients must have adequate organ and marrow function within 30 days of starting treatment.
✓. Patients must be able to provide written informed consent.
Exclusion criteria
✕. Patients receiving any other standard or investigational agents are ineligible.
✕. Patients with history or current evidence of the following conditions are excluded: neuromuscular disorder with associated elevated CK (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy), pancreatitis, retinal vein occlusion, uncontrolled HIV, or Hepatitis B/C. An exception will be made for (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and for subjects with cleared HBV and HCV infections, who may enroll in the study.
What they're measuring
1
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
Timeframe: Up to 1 year
Trial details
NCT IDNCT03973918
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
✕. Known hypersensitivity or contraindication to any component of binimetinib or encorafenib or their excipients
✕. Current use of a prohibited medication (including herbal medications, supplements, or foods), or use of a prohibited medication ≤ 7 days prior to the start of study treatment.
✕. Patient has not recovered to ≤ Grade 1 non-hematologic toxic effects of prior therapy before starting study treatment. Note: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll.
✕. Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following:
✕. Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drug (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, small bowel resection with decreased intestinal absorption), or recent (≤ 90 days) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs.
✕. History of recent (≤ 90 days) thromboembolic or cerebrovascular event such as transient ischemic attack, cerebrovascular accident, or hemodynamically significant (massive or sub-massive) deep vein thrombosis or pulmonary emboli (DVT/PE). Note: Patients with DVT/PE that does not result in hemodynamic instability may enroll as long as they are anticoagulated for at least 4 weeks. Note: Patients with DVT/PE related to indwelling catheters or other procedures may enroll.